[Federal Register Volume 73, Number 125 (Friday, June 27, 2008)]
[Proposed Rules]
[Pages 36696-36719]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-13280]
[[Page 36695]]
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Part III
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 405, 410, and 491
Medicare Program; Changes in Conditions of Participation Requirements
and Payment Provisions for Rural Health Clinics and Federally Qualified
Health Centers; Proposed Rule
Federal Register / Vol. 73, No. 125 / Friday, June 27, 2008 /
Proposed Rules
[[Page 36696]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 405, 410, and 491
[CMS-1910-P2]
RIN 0938-AJ17
Medicare Program; Changes in Conditions of Participation
Requirements and Payment Provisions for Rural Health Clinics and
Federally Qualified Health Centers
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
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SUMMARY: This proposed rule would establish location requirements
including exception criteria for rural health clinics (RHCs). It would
also require RHCs to establish a quality assessment and performance
improvement (QAPI) program. In addition, it would: Clarify our policies
on ``commingling'' of an RHC with another entity; revise the RHC and
Federally Qualified Health Centers (FQHC) payment methodology and
exceptions to the per-visit payment limit to implement statutory
requirements; revise RHC and FQHC payment requirements for services
furnished to skilled nursing facility (SNF) patients; allow RHCs to
contract with RHC nonphysician providers under certain circumstances;
and update the regulations pertaining to waivers to the staffing
requirements. This proposed rule would also add requirements for RHCs
and FQHCs to maintain and document an infection control process and to
post RHC or FQHC hours of clinical services. In addition, this proposed
rule would update the requirements under the emergency services
standard and patient health records condition for certification (CfC)
to reflect advancements in technology and treatment. Finally, this
proposed rule solicits comments on payment for high cost drugs and the
appropriateness of a mental health specialty clinic as an exception to
the location requirements.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on August 26, 2008.
ADDRESSES: In commenting, please refer to file code CMS-1910-P2.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the instructions for
``Comment or Submission'' and enter the CMS-1910-P2 to find the
document accepting comments.
2. By regular mail. You may mail written comments (one original and
two copies) to the following address ONLY: Centers for Medicare &
Medicaid Services, Department of Health and Human Services, Attention:
CMS-1910-P2, P.O. Box 8010, Baltimore, MD 21244-8010.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments (one
original and two copies) to the following address ONLY: Centers for
Medicare & Medicaid Services, Department of Health and Human Services,
Attention: CMS-1910-P2, Mail Stop C4-26-05, 7500 Security Boulevard,
Baltimore, MD 21244-1850.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments (one original and two copies) before the
close of the comment period to either of the following addresses:
a. Room 445-G, Hubert H. Humphrey Building, 200 Independence
Avenue, SW., Washington, DC 20201.
(Because access to the interior of the HHH Building is not readily
available to persons without Federal Government identification,
commenters are encouraged to leave their comments in the CMS drop slots
located in the main lobby of the building. A stamp-in clock is
available for persons wishing to retain a proof of filing by stamping
in and retaining an extra copy of the comments being filed.)
b. 7500 Security Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
please call telephone number (410) 786-7195 in advance to schedule your
arrival with one of our staff members.
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
Submission of comments on paperwork requirements. You may submit
comments on this document's paperwork requirements by following the
instructions at the end of the ``Collection of Information
Requirements'' section in this document.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Corinne Axelrod, (410) 786-5620. Rural
health clinic location requirements and exceptions, staffing and
payment. Mary Collins, (410) 786-3189 and Scott Cooper (410) 786-9465.
Quality assessment and performance improvement and health and safety
standards.
SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments
received before the close of the comment period are available for
viewing by the public, including any personally identifiable or
confidential business information that is included in a comment. We
post all comments received before the close of the comment period on
the following Web site as soon as possible after they have been
received: http://www.regulations.gov. Follow the search instructions on
that Web site to view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.
Abbreviations and Acronyms
AED--Automated External Defibrillator
BBA--Balanced Budget Act of 1997
BIPA--Medicare, Medicaid, and SCHIP Benefits Improvement and
Protection Act of 2000
CAH--Critical Access Hospital
CDC--Centers for Disease Control and Prevention
CfC--Condition for Certification
CMS--Centers for Medicare & Medicaid Services
CNM--Certified Nurse-Midwife
CNS--Clinical Nurse Specialist
CoP--Condition of Participation
CP--Clinical Psychologist
CSW--Clinical Social Worker
DRA--Deficit Reduction Act
DSMT--Diabetes Self-Management Training
FI--Fiscal Intermediary
FQHC--Federally Qualified Health Center
GAO--Government Accountability Office
GDSC--Governor-Designated and Secretary-Certified Shortage Areas
HHS--Department of Health and Human Services
HPSA--Health Professional Shortage Area
HRSA--Health Resources and Services Administration
MAC--Medicare Administrative Contractor
[[Page 36697]]
MMA--Medicare Prescription Drug, Improvement, and Modernization Act
of 2003
MUA--Medically Underserved Area
MUP--Medically Underserved Population
NP--Nurse Practitioner
OBRA--Omnibus Budget Reconciliation Act
OIG--Office of the Inspector General
OMB--Office of Management and Budget
PA--Physician Assistant
PHS--Public Health Service
PPS--Prospective Payment System
PRA--Paperwork Reduction Act
QAPI--Quality Assessment and Performance Improvement
RFA--Regulatory Flexibility Act
RHC--Rural Health Clinic
RO--Regional Office
RUCA--Rural Urban Commuting Area
SCHIP--State Children's Health Insurance Program
SNF--Skilled Nursing Facility
UA--Urbanized Area
UIC--Urban Influence Code
USDA--United States Department of Agriculture
Table of Contents
I. Background
A. Publication and Suspension of the December 24, 2003 Final
Rule
B. Summary of Provisions of the December 24, 2003 Final Rule
C. Origin of the RHC/FQHC Programs
D. Growth of the RHC Program
1. Continuing Participation
2. Medically Underserved/Shortage Area Designations
3. Expansion of Eligible Designations for RHC Certification
4. Commingling
E. Government Reports on RHCs
II. Provisions of This Proposed Rule
A. RHC Location Requirements and Exceptions
1. RHC Location Requirements
2. Essential Provider Requirements
3. Location Exception Criteria
4. Process for Essential Providers Status and Timeline
B. Staffing Requirements, Waivers, and Contracts
1. Staffing Requirements
2. Temporary Staffing Waivers
3. Contractual Arrangements
C. Payment Issues
1. Payment Methodology for RHC and FQHCs
2. Exceptions to the Per Visit Payment Limit
3. Commingling
4. Payment for Services to Hospital Patients
5. Payment for Services to Skilled Nursing Facility (SNF)
Patients
6. Payment for Certain Physician Assistant Services
7. Screening Mammography
8. Payment for High Cost Drugs
D. Health and Safety, and Quality
1. Quality Assessment & Performance Improvement Program (QAPI)
2. Infection Control
3. Hours of Operation
a. Posting of Hours
b. Use of the RHC Facility
4. Emergency Services and Training
5. Patient Health Records
E. Other Proposed Changes
1. General
2. FQHCs
III. Collection of Information Requirements
IV. Regulatory Impact Analysis
Regulation Text
I. Background
A. Publication and Suspension of the December 24, 2003 Final Rule
On February 28, 2000, we published a proposed rule in the Federal
Register (65 FR 10450) entitled ``Rural Health Clinics: Amendments to
Participation Requirements and Payment Provisions; and Establishment of
a Quality Assessment and Performance Improvement Program.'' This
proposed rule revised certification and payment requirements for rural
health clinics (RHCs) as required by the Balanced Budget Act of 1997
(BBA), Public Law 105-33, enacted on August 5, 1997. We issued the
final RHC rule on December 24, 2003 (68 FR 74792).
On December 8, 2003, the Medicare Prescription Drug, Improvement,
and Modernization Act of 2003 (MMA) (Pub. L. 108-173) was enacted.
Section 902 of the MMA amended section 1871(a) of the Social Security
Act (the Act) and requires the Secretary, in consultation with the
Director of the Office of Management and Budget (OMB), to establish and
publish timelines for the publication of Medicare final regulations
based on the previous publication of a Medicare proposed or interim
final regulation. Section 902 of the MMA also states that ``[s]uch
timeline may vary among different regulations based on differences in
the complexity of the regulation, the number and scope of comments
received, and other relevant factors, but shall not be longer than 3
years except under exceptional circumstances.''
To comply with the MMA requirement to publish a final rule not more
than 3 years after a proposed rule, we suspended the effectiveness of
the December 24, 2003 final rule on September 22, 2006 (71 FR 55341).
The Code of Federal Regulations currently reflects the regulations in
effect before December 2003.
While section 902 of the MMA did not explicitly prohibit the
Secretary from finalizing all proposed rules that were published as an
interim or proposed rule more than 3 years before December 8, 2003, we
chose to take this opportunity to propose additional updates and
clarifications of the provisions published in the previous rule, and
provide the public with the opportunity to comment on these proposals.
B. Summary of the Provisions of the December 24, 2003 Final Rule
The December 24, 2003 final rule addressed comments received on the
February 28, 2000 proposed rule, and finalized policies regarding RHC
and federally qualified health center (FQHC) payment and participation
in the Medicare program. It established: (1) Criteria and a process to
decertify RHCs which no longer serve rural or medically underserved
areas (MUAs), as required by the BBA; (2) a policy that would have
prohibited the commingling of RHC resources with another entity's
resources; and (3) a requirement that RHCs establish a quality
assessment and performance improvement (QAPI) program.
The December 24, 2003 final rule also updated payment policies and
regulations to conform to statutory requirements of the Omnibus Budget
Reconciliation Acts (OBRA) '86, '87, '89, and '90 and the MMA.
For the reasons specified in section I.A. of this proposed rule,
these provisions have been suspended.
C. Origin of the RHC/FQHC Programs
The Rural Health Clinic Services Act of 1977 (Pub. L. 95-210)
enacted on December 13, 1977, amended the Act by adding section
1861(aa) of the Act to extend Medicare and Medicaid entitlement and
payment for primary and emergency care services furnished at an RHC by
physicians and certain ``nonphysician practitioners,'' and for services
and supplies incidental to their services. ``Nonphysician
practitioners'' included nurse practitioners (NPs) and physician
assistants (PAs). (Subsequent legislation extended the definition of
covered RHC services to include the services of clinical psychologists
(CPs), clinical social workers (CSWs), and certified nurse-midwives
(CNMs).)
According to House Report No. 95-548(I), the purpose of the Rural
Health Clinic Services Act was to address an inadequate supply of
physicians serving Medicare beneficiaries and Medicaid recipients in
rural areas. The legislation addressed this problem by authorizing CMS
and States to pay qualifying clinics on a cost-related basis for
providing Medicare beneficiaries and Medicaid recipients, respectively,
with outpatient physician and certain nonphysician services. (The
Medicare payment provisions for RHCs are in sections 1833(a)(3) and
1833(f) of the Act and in regulations at Sec. 405.2462 through Sec.
405.2468.) Payment to RHCs for services furnished to beneficiaries is
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made on the basis of an all-inclusive payment methodology subject to a
maximum payment per-visit and annual reconciliation.
Qualifying clinics, among other criteria, must be located in an
area that is determined to be nonurbanized by the U.S. Census Bureau.
The clinic also must be located in an area designated as a shortage
area either by the Health Resources and Services Administration (HRSA)
or by the chief executive officer of the State and certified by the
Secretary, Department of Health and Human Services (HHS). (See section
1861(aa)(2) of the Act, following subparagraph (K).)
Qualifying clinics also must employ a PA or NP and, to meet
requirements of the OBRA '89, must have a NP, a PA, or a CNM available
to furnish patient care services at least 5.0 percent of the time the
RHC operates.
The FQHC Medicare coverage and payment benefit was provided for in
OBRA '90, Public Law 101-508, enacted on November 5, 1990, and
implemented in the Federal Register (57 FR 24961) on June 12, 1992. On
April 3, 1996, we published a final regulation (61 FR 14640) that
addressed the issues raised by commenters on the June 1992 rule.
OBRA '90 defines an FQHC as an entity that is receiving a grant
under section 329, section 330, or section 340 of the Public Health
Service Act (PHS). The definition of an FQHC was expanded by section
13556(a)(3) of OBRA '93 (Pub. L. 103-66) enacted on August 10, 1993,
effective as if included in OBRA '90 on October 1, 1991. The expanded
definition included outpatient programs or facilities operated by a
tribal organization under the Indian Self-Determination Act, or by an
urban Indian organization receiving funds under Title V of the Indian
Health Care Improvement Act.
The FQHC scope of benefits for core services is similar to the RHC
benefit, that is, physician, nonphysician practitioner, and mental
health professional services. The FQHC benefit also includes a number
of preventive services.
Each FQHC is reimbursed its reasonable costs based on an all-
inclusive per-visit methodology subject to tests of reasonableness, and
is subject to an overall payment limit similar to RHCs. The national
FQHC payment limit is based on the costs of providing primary care
physician and prevention services. For FQHC services, there are two
upper payment limits: One limit is for centers located in urban areas
and the other is for centers located in rural areas.
D. Growth of the RHC Program
The RHC program has grown from less than 1,000 Medicare-approved
RHCs in 1992 to more than 3,700 in 2008. However, since 2001, growth in
the program has leveled off. While part of this increase has improved
access to primary care services in rural areas for Medicare
beneficiaries and Medicaid recipients, there are instances in which
these additional RHCs have not expanded access.
1. Continuing Participation
A significant factor in the growth of RHCs stems from the original
(pre-BBA) RHC legislation, which included a ``grandfather clause'' to
promote the development of RHCs. (See section 1(e) of the Health Clinic
Services Act of 1977 (Pub. L. 95-210) enacted December 13, 1977, 42
U.S.C. 1395x note. Also see Sec. 491.5(b)(2) of the regulations.)
Section 1861(aa)(2) of the Act stated that any RHC that subsequently
failed to satisfy the requirements pertaining to the rural and
underserved location requirement still would be deemed to have
satisfied the requirement of that clause.
These provisions protected the clinics' RHC status regardless of
any changes to the rural or underserved status of the service areas. It
allowed clinics to remain in the RHC program even though the service
areas no longer were considered rural or medically underserved.
The Congress established these protections to encourage clinics to
attract needed health care professionals to underserved rural areas and
to retain them without being concerned about losing the shortage area
designation, which would make the clinics ineligible for RHC status and
its reimbursement incentives. Once the clinic successfully attracted
the needed health care professionals to the area, the Congress wanted
to ensure that the service area did not return to its previous
underserved status because we removed the clinic's RHC status and
reimbursement incentives.
Although the grandfather clause provision was an appropriate policy
at the time, we now have RHC participation in some service areas with
extensive health care delivery systems that provide adequate access to
primary care for Medicare beneficiaries and Medicaid recipients. Both
the Government Accountability Office (GAO) and the HHS Office of the
Inspector General (OIG) recommended the establishment of a mechanism,
under the survey and certification process for Medicare facilities, to
discontinue RHC status and its payment incentives in those service
areas where they are no longer justified. In section 4205(d)(3) of the
BBA, the Congress responded to these recommendations by amending the
grandfather clause provision to provide protection only to clinics
essential to the delivery of primary care in the respective service
area.
2. Medically Underserved/Shortage Area Designations
Another reason for the continued growth of the RHC program was that
two of the types of shortage area designations that are used for RHC
certification, the medically underserved area (MUA) and the Governor-
Designated Secretary-Certified Shortage Area (GDSC) designations, did
not have a statutory requirement for regular review and were not
reviewed systematically and updated after their initial designation. As
a result, some RHCs are in areas that no longer would be designated as
underserved if reviewed with current data. In response, the Congress
amended the legislation in section 4205(d) of the BBA by requiring that
only those clinics located in shortage areas that were designated or
updated within the previous 3 years would qualify for purposes of the
RHC program.
3. Expansion of Eligible Designations for RHC Certification
Section 6213 of OBRA '89 amended section 1861(aa)(2) of the Act to
expand the types of shortage areas eligible for RHC certification.
Until then, the eligible areas included only those designated by the
Secretary as areas having a shortage of personal health services under
section 330(b)(3) of the PHS Act (medically underserved areas (MUAs))
and those designated as geographic health professional shortage areas
(HPSAs) under section 332(a)(1)(A) of the PHS Act. The OBRA '89
amendment expanded the eligible areas to also include: high impact
migrant areas designated under section 329(a)(5) of the PHS Act; areas
containing a population group HPSA designated under section
332(a)(1)(B) of the PHS Act; and areas designated by the Governor of a
State and certified by the Secretary as having a shortage of personal
health services. However, later, the Health Centers Consolidation Act
of 1996 (Pub. L. 104-299) renumbered section 329 of the PHS Act and
repealed the requirement for designation of high impact migrant areas.
4. Commingling
The growth of RHCs may have also been stimulated by the practice of
[[Page 36699]]
``commingling.'' The term ``commingling'' is used to describe the
sharing of RHC space, staff, supplies, records, or other resources with
a private Medicare practice or other entity operated by the same
physician and nonphysician practitioners working for the RHC, during
RHC hours of operation. We recognize that providing care in rural areas
that have limited infrastructure and providers requires the
coordination of scarce resources, and permit the sharing of resources
in certain situations. In some of these situations, however, it is
believed that commingling has been used to maximize Medicare payment by
obtaining RHC status for an integrated practice that submits both RHC
and non-RHC Medicare claims.
E. Government Reports on RHCs
The GAO report, ``Rural Health Clinics: Rising Program Expenditures
Not Focused on Improving Care in Isolated Areas'' (GAO/HHS-97-24,
November 22, 1996), and the HHS/IG report ``Rural Health Clinics:
Growth, Access and Payment'' (OEI-05-94-00040, July 1996), both
concluded that the growth of RHCs is not proportional to community need
and that many RHCs no longer require cost-based reimbursement as a
payment incentive. They also concluded that the payment methodology for
provider-based RHCs lacks sufficient cost controls and recommended
establishing payment limits and screens on reasonable costs for these
providers. (A provider-based RHC is an integral and subordinate part of
a Medicare participating hospital, critical access hospital (CAH),
skilled nursing facility (SNF), or home health agency (HHA), and is
operated with other departments of the provider under common
governance, professional supervision, and usually licensure. All other
RHCs are considered to be independent.)
In August 2005, the OIG issued a followup report, ``Status of the
Rural Health Clinic Program'' (OEI-05-03-00170), which recommended that
HRSA review shortage designations within the requisite 3-year period
and publish regulations to revise its shortage designation criteria.
The report also suggested that CMS issue regulations to: (1) Ensure
that RHCs determined to be essential providers remain certified as
RHCs; and (2) require prospective RHCs to document need on access to
health care in rural underserved areas.
II. Provisions of This Proposed Rule
A. RHC Location Requirements and Exceptions
1. RHC Location Requirements
In sections 4205(d)(1) and (2) of the BBA, the Congress amended
section 1861(aa)(2) of the Act. As revised, the statute states that
RHCs may include only a facility which is located in: (1) A
nonurbanized area, as defined by the U.S. Census Bureau; (2) an area in
which there are an insufficient number of needed health care
practitioners as determined by the Secretary; and (3) an area that has
been designated or certified by the Secretary within the previous 3
years as having an insufficient number of needed health care
practitioners.
Section 4205(d)(3)(A) of the BBA, which amended the third sentence
of section 1861(aa)(2) of the Act, revised the ``grandfather clause''
that permitted an exception to the termination of RHC status for a
clinic located in an area that is no longer a rural area or a shortage
area. This revision specified that an exception was available only if
the RHC was determined to be essential to the delivery of primary care
services that would otherwise be unavailable in the geographic area
served by the RHC. These amendments were made effective upon issuance
of implementing regulations that the Congress directed CMS to issue by
January 1, 1999. The BBA requirement that every RHC must have a current
shortage area designation (made or updated within the previous 3-year
period), has been implemented for new RHCs through administrative
instructions.
To determine if a facility is in a nonurbanized area, we propose
that the most recently available U.S. Census Bureau list of Urbanized
Areas (UA) be used. An area that is not in a UA would be considered a
nonurbanized area. Information on whether an area is urbanized can be
found at http://factfinder.census.gov or by contacting the appropriate
CMS Regional Office (RO) at http://www.cms.hhs.gov/RegionalOffices.
To determine if a facility is in an area that has a current
designation as an underserved or shortage area, the most current HRSA
list of these designations would be used. Information on designation
status, including the date of the most recent designation or update, is
available on the HRSA Web site at http://hpsafind.hrsa.gov/ and http://
muafind.hrsa.gov or by contacting the appropriate CMS RO.
Health professional shortage area (HPSA) and MUA designations
establish initial eligibility for Federal and State programs to improve
access to health care services. They are based on established criteria
(42 CFR part 5) to identify geographic areas or population groups with
a shortage of primary health care services. HPSA designations are based
primarily on the population to provider ratio in a defined service
area. MUA designations utilize an Index of Medical Underserviced which
calculates a score for each area based on a weighted combination of the
ratio of primary medical care physicians per 1,000 population, infant
mortality rate, percentage of the population with incomes below the
poverty level, and percentage of the population age 65 or over.
(Note: HRSA has proposed a revision of the methodology used for
determining HPSA and MUA designations. If necessary, this
description of the designations will be updated in the final rule.
Any change that HRSA makes to the methodology used to determine
designations will not alter the requirements for the RHC program.)
Any of the following types of designations are acceptable for the
purpose of RHC certification and compliance with this proposed
requirement:
Geographic Primary Care HPSAs (section 332(a)(1)(A) of the
PHS Act)
Population-group Primary Care HPSAs (section 332(a)(1)(B)
of the PHS Act)
MUAs (This does not include population group Medically
Underserved Population designations) (Section 330(b)(3) of the PHS Act)
Governor-designated and Secretary-certified shortage
areas. (section 6213(c) of OBRA '89 (Pub. L. 101-239))
In section 302(a)(1)(A) of the Health Care Safety Amendments of
2002 (Pub. L. 107-251, October 26, 2002), the Congress amended section
332 of the PHS Act to create a new type of HPSA designation for FQHCs
and RHCs referred to as an ``automatic'' HPSA designation. This type of
designation is available to any RHC or FQHC irrespective of its
physical location that utilizes sliding scale fees consistent with
section 330 of the PHS Act for the purpose of National Health Service
Corps eligibility. Facilities with these automatic HPSA designations
are sometimes referred to as ``safety net facilities.'' However, we are
proposing not to include the automatic HPSA designations as an eligible
shortage area for purposes of Medicare qualifications as an RHC.
Section 1861(aa)(2) of the Act specifically requires RHCs to be located
in one of four specified designation types in which the Secretary has
determined that there are
[[Page 36700]]
insufficient numbers of needed practitioners. Consequently, we would
not recognize automatic HPSA designations for purposes of RHC
certification or protecting a currently participating clinic from RHC
decertification.
New and existing RHCs would have to be in a rural area that is
currently designated as one of the four types of shortage areas listed
previously. A designation is considered current for not more than 3
years after the date of the original designation or the date of the
most recent update to the designation. An existing RHC that no longer
meets would not be decertified based on the loss of its shortage area
designation if: (1) A complete designation application has been
received by HRSA before the end of the 3-year period since the shortage
area designation date or most recent update; or (2) we have determined
that the RHC is an essential provider. If either of these conditions is
not met, the clinic would be terminated from participation in the
Medicare program as an RHC 180 days after the date that the RHC no
longer meets the location requirements, effective the last day of the
month. States are encouraged to submit designation applications and
updates to HRSA in a timely manner and may apply or reapply for a
designation at any time.
2. Essential Provider Requirements
The RHC program was established for the purpose of improving and
maintaining access to primary care for rural underserved communities.
RHCs that apply to CMS for an exception to the location requirements
must be able to show that they satisfy this program objective.
In accordance with section 1861(aa)(2) of the Act, an existing RHC
may be considered essential to the delivery of primary care (a so-
called ``essential provider'') if the care otherwise would be
unavailable in the geographic area served by the clinic. The Secretary
is directed by the Act to set the criteria by which ``essential
provider'' status is to be determined. The Secretary has determined
that an RHC may be considered an essential provider and be granted an
exception to the location requirements if the clinic is no longer in a
nonurbanized area or it is no longer in a currently designated shortage
area, and it meets the criteria of an essential provider. An RHC that
is neither in a rural area nor a designated area would not be
considered an essential provider. Proposed criteria for essential
provider status were published in the February 2000 proposed rule and
have been revised based on comments that were received and other
relevant information.
Under this authority, we are proposing the following requirements
for essential provider status:
If an RHC is located in an area that has been classified as a UA by
the U.S. Census Bureau, it would have to be in a level 4 or higher
Rural Urban Commuting Area (RUCA) to assure that it is in a rural area.
Under section 330A of the PHS Act, HRSA's Office of Rural Health Policy
determines eligibility for its rural grant programs through the use of
the RUCA code methodology. Under this methodology, any census tract
that is in a RUCA level 4 or higher is determined to be a rural census
tract. For the purposes of an exception to the RHC nonurbanized area
location requirement, we would use the RUCA level 4 as the minimum
level of rurality to meet this requirement.
Additionally, an RHC that is located in an area that has been
classified as a UA by the U.S. Census Bureau would have to demonstrate
that at least 51 percent of its patients reside in an adjacent nonurban
area in order to be considered essential for the purposes of an
exception to the location requirements. We prefer to give RHCs
flexibility in establishing that at least 51 percent of their patients
reside in an adjacent nonurban area; however, this could generally
include the identification of the nonurban area(s) and a retrospective
review of patient visits to determine residence, or other factors to
support that the requirement has been met.
3. Location Exception Criteria
We are proposing to revise Sec. 491.5 to specify that an RHC that
meets the previously stated requirements may apply for an exception if
it meets any one of the following criteria:
Sole Community Provider (proposed Sec. 491.5(c)(1)): The
RHC is the only participating primary care provider that meets either
of the following requirements:
++ The RHC is at least 25 miles from the nearest participating
primary care provider; or
++ The RHC is at least 15 miles but less than 25 miles from the
nearest participating primary care provider and can demonstrate that it
is more than 30 minutes from the nearest primary care provider based on
local topography, predictable weather conditions, or posted speed
limits. (These criteria are based on the criteria established for sole
community hospitals in Sec. 412.92.) For purposes of this exception, a
participating primary care provider would mean another RHC, FQHC, or
primary care provider that is actively accepting and treating Medicare
beneficiaries, Medicaid recipients, low-income patients, and the
uninsured (regardless of their ability to pay).
Major Community Provider (proposed Sec. 491.5 (c)(2)):
The RHC meets the following requirements:
++ Has a Medicare, Medicaid, low-income, and uninsured patient
utilization rate greater than or equal to 51 percent, or a low-income
patient utilization rate greater than or equal to 31 percent; and
++ Is actively accepting and treating a major share of Medicare,
Medicaid, low-income and uninsured patients (regardless of their
ability to pay) compared to other participating primary care providers
that are within 25 miles of the RHC.
Specialty Clinic: Obstetrics/Gynecology (Ob/Gyn) or
Pediatrics (proposed Sec. 491.5(c)(3)): The RHC meets the following
requirements:
++ Exclusively provides ob/gyn or pediatric health services (as
applicable).
++ Is the sole or major source of ob/gyn or pediatrics for Medicare
(where applicable), Medicaid, and uninsured patients (regardless of
their ability to pay) and is either of the following:
--At least 25 miles from the nearest participating provider of ob/gyn
or pediatric services.
--At least 15 miles but less than 25 miles from the nearest
participating provider of ob/gyn or pediatric services, and can
demonstrate that it is more than 30 minutes from the nearest
participating primary care provider providing these services based on
local topography, predictable weather conditions, or posted speed
limits.
++ Is actively accepting and treating Medicare, Medicaid, low-
income, and uninsured patients.
++ Has a Medicare, Medicaid, low-income patient and uninsured
utilization rate greater than or equal to 31 percent.
++ Provides ob/gyn (including prenatal care) or pediatric services
onsite to clinic patients.
Extremely Rural Community Provider (Proposed Sec.
491.5(c)(4)): The RHC meets the following requirements:
++ Is actively accepting and treating Medicare, Medicaid, low-
income, and uninsured patients (regardless of their ability to pay).
++ Is located in a frontier county (a county with 6 or less persons
per square mile) or in census tract or zip code with a RUCA code 10.
In the December 2003 final rule, we included RHC's that are mental
health
[[Page 36701]]
specialty clinics as an acceptable category for an exception to the
location requirements. However, section 1861(aa)(2)(iv) of the Act
prohibits RHC status from being applied to clinics which are
``primarily for the care and treatment of mental diseases.'' We
interpret ``primarily'' to mean that mental health services provided by
the RHC cannot constitute more than 50 percent of the total services
provided by the RHC.
In order to assure that the regulation and statue are consistent,
we are asking for comments on--(1) whether it is appropriate to allow
an exception to the location requirements for RHCs based on the
provision of mental health services in light of the fact that RHC
status cannot be granted to a facility providing more than 50 percent
of its total services in mental health; and (2) if so, what should be
the minimum level of mental health services provided in order to
qualify for an exception. This would apply only to existing an RHC that
no longer meet the location requirements, either because it is no
longer in a non-urbanized area, or because it is no longer designated
by HRSA as an underserved or shortage area. Existing RHCs that are in
compliance with the location requirements may continue to provide
mental health services as long as the mental health services provided
do not exceed 50 percent of the total clinic services.
4. Process for Essential Provider Status and Timeline
An RHC that is located in (a) an area that has not been designated
or its designation was not been updated for more than 3 years, or (b)
an urbanized area that is defined by the Census Bureau, would have 90
calendar days from the effective date of the final rule to apply to CMS
RO for an exception to the location requirement. The RHC may continue
to operate as an RHC for an additional 90 days, for a total of 180
calendar days after the end of the 3-year period. To assist with the
cost reporting and payment reconciliation process, decertification
would be effective on the last day of the month in which the 180-day
limit was met.
An RHC would have 180 days after the date that it does not meet the
location requirements to continue operating as an RHC. We expect that
most RHCs that do not meet the location requirements would want to know
as soon as possible if they would receive an exception to the location
requirements and would want as much time as possible to make other
arrangement for the provision of services after the 180 days, so it is
in the interest of the RHC to apply for an exception to the location
requirements as soon as possible.
An RHC which is located in an area which has been found by HRSA to
no longer qualify for one of the 4 types of eligible designations would
have 90 calendar days from the date HRSA determined that the area no
longer qualified for one of the eligible designations to apply to CMS
RO for an exception from decertification. This would include
designations that are proposed for withdrawal, as well as areas whose
designations type has changed to one that does not meet the RHC
criteria.
For example, if HRSA determines on April 1, 2009, that the area no
longer qualifies for one of the designations required for RHC purposes,
the RHC would have until June 30, 2009 to submit an application to the
appropriate RO for a location exception, and would be protected until
September 30, 2009 from decertification based on not meeting the
location requirements.
An RHC which is located in an area whose designation has not been
updated in a timely manner and which does not apply for a location
exception may continue to operate as an RHC for 180 calendar days after
the 3 years from the date of the last designation, effective the last
day of the month.
An RHC may be decertified 180 days after the 3-year date of the
area's designation if it does not provide a complete application for a
location exception within 90 days from the date it no longer meets the
location requirements, or if the application for a location exception
is not approved. In rare circumstances, the RO may request an extension
from the CMS Central Office if it has not been possible to process the
location exception request before the RHC would be decertified.
For example, (see accompanying sample timeline) if an area was
designated (either a new designation or an update) on January 2, 2006
(1 on sample timeline), the designation would be considered
valid for RHC purposes for 3 years, which would be January 2, 2009
(2). If an application to update the designation is submitted
to HRSA by January 2, 2009 (3), the RHC would be protected
from decertification while the HPSA application is under review
(3.1). If the area qualifies as a HPSA and is updated
(3.2), then no further action would be needed for purposes of
the RHC designation for 3 years from the date of the designation update
(3.3). If a HPSA application is submitted by January 2, 2009
(3), but is determined to not qualify as a HPSA
(3.1.1), then the RHC would have 90 days from the date of that
determination to submit an application for an exception
(3.1.2).
If an application to update the designation is not submitted to
HRSA by January 2, 2009 (4), the RHC would have until April 3,
2009 (4.1), to submit an application for a location exception.
If the RHC does not submit an application for a location exception to
CMS by April 3, 2009 (4.2), it would be decertified on July
31, 2009 (4.3). (Decertification is effective the final day of
the month.)
An RHC that submits an application for a location exception would
be protected from decertification while the application is under review
(5). If the application is approved (5.1), then no
further action would be needed for purposes of the RHC recertification
for 3 years from the date of the exception (5.1.1). If the
application is not approved (5.2), the RHC would be
decertified 90 days from the date of notification that the application
was not approved (5.2.1).
The process to appeal a denial of certification is described in
Sec. 498.3(b)(5). For the purpose of an appeal, RHCs and FQHCs are
considered suppliers, not providers.
In the December 24, 2003 final rule, we stated that an RHC would
have 120 days from the date of notification that it was no longer in a
designated area and therefore not compliant with the RHC requirements
to submit an application to update its MUA or HPSA designation.
Although HRSA regulations do not preclude RHCs from submitting a
designation application, it is usually the State not the RHC that
submits the designation application. The State should not wait until a
designation is more than 3 years old to prepare and submit an update
for RHC purposes. As noted previously, an existing RHC is protected
from decertification based on its designation status as long as an
application has been submitted for an updated designation. We encourage
RHC to work with the applicable State Primary Care Office to assure
that any necessary information is provided to HRSA in a timely manner.
A list of the State Primary Care Offices is available online at http://
hrsa.gov/grants and then by selecting ``HRSA Grantees by Program or
State'' and then by selecting ``State Primary Care Offices'', or by
contacting the State's Department of Health.
An RHC that chooses to apply for an exception to the location
requirements would send its application with the necessary
documentation to the appropriate RO. An RHC that applied for an
exception would not be
[[Page 36702]]
disqualified as an RHC based on not meeting the location requirements
while its application is under review. If approved, the exception would
be for a period of 3 years. Every 3 years, an RHC may reapply for an
exception to the location requirements to continue its RHC eligibility.
Some provider-based RHCs that do not meet the location requirements
and do not qualify for an exception may want to continue to operate as
another type of Medicare provider. In some cases, these entities will
need to go through the standard Medicare application process, which
includes an application and, for entities wishing to enroll as a
``provider of services'' under 1861(u), a state survey. We have been
informed that the waiting time for a state survey can be several
months, so we are proposing that provider-based RHCs that do not meet
the location requirements and do not qualify for an exception and have
submitted an application to CMS to be another type of Medicare provider
that requires a State survey for certification may receive an
additional 120-day extension of their status as an RHCs while their
application is being processed.
We propose to revise Sec. 491.2 to redefine ``shortage areas'' as
geographic and population group HPSAs, MUAs, and areas designated by
the Governor of the State and certified by the Secretary.
We propose to amend Sec. 491.3 as follows by adding paragraphs
(a)(1) through (a)(3) to specify general certification requirements,
and (b)(1) to specify permanent and mobile unit requirements.
We propose to amend Sec. 491.5 as follows:
Adding paragraphs (a)(1) through (a)(3) to specify the
location requirements for RHCs and FQHCs.
Adding paragraph (a)(4) to specify when a clinic would be
terminated from the RHC program.
Adding paragraphs (a)(5) and (a)(6) to specify the
requirements for being considered an essential provider.
Adding paragraph (a)(7) to specify the time period for a
clinic's essential provider status.
Adding paragraph (a)(8) to specify the time period that a
decertified RHC may continue to operate.
Adding paragraph (a)(9) to specify that conditions for an
extension of RHC status when the location requirements are not met and
the clinic does not qualify for an exception.
Adding paragraphs (b)(1) through (b)(4) to specify the
criteria for an exception from the location requirements.
Adding paragraphs (c)(1) and (c)(2) to specify the
conditions for termination.
Adding paragraphs (d)(1) through (d)(8) to set forth the
circumstances and timeline for submitting a request for an exception to
the location requirements.
BILLING CODE 4120-01-P
[[Page 36703]]
[GRAPHIC] [TIFF OMITTED] TP27JN08.006
BILLING CODE 41210-01-C
[[Page 36704]]
B. Staffing Requirements, Waivers, and Contracts
1. Staffing Requirements
One of the goals of the RHC program is to encourage the use of
nonphysician practitioners to provide quality health care in rural
areas. We propose to amend Sec. 491.8(a)(6) to conform with section
6213(a)(3) of OBRA '89 (Pub. L. 101-239) which requires that an NP, PA,
or CNM be available to furnish patient care at least 50 percent of the
time the RHC operates. An RHC that opens its premises solely to address
administrative matters or to allow patients shelter from inclement
weather would not be considered to be in operation as an RHC during
that period.
2. Temporary Staffing Waivers
We propose to amend Sec. 491.8(d) to conform with section
1861(aa)(7) of the Act, which authorizes us to grant a 1-year waiver of
staffing requirements for nonphysician primary care providers (NPs,
PAs, or CNMs) upon request from the RHC. The requesting RHC would have
to demonstrate that it made a good faith effort to recruit and retain
an adequate number of nonphysician primary care providers, and that it
has been unable in the 90-day period prior to the request to hire one
of these providers to meet the staffing requirement. This could include
activities such as advertising in a newspaper, advertising in a
professional journal, conducting outreach to an NP, PA, or CNM school,
or other activities that would demonstrate a good faith effort to
recruit and retain a nonphysician primary care provider. In accordance
with section 1861(aa)(7)(B) of the Act, this waiver would be available
only to existing RHCs that meet the nonphysician primary care
requirement before seeking the waiver.
Section 1861(aa)(7) of the Act also specifies that an additional
waiver cannot be granted until a minimum of 6 months has passed since
the expiration of the previous waiver.
We are proposing that an RHC that has not complied with staffing
requirements for one or more nonphysician primary care providers and
has not submitted a request for a waiver of this requirement would be
decertified from the RHC program. The decertification would be
mandatory, since the noncompliant facility would fail to meet the
statutory definition of an RHC. An RHC that has submitted a waiver
request would not be decertified based on this requirement while its
request was under review. A waiver would be deemed granted after 60
days, unless written notification is provided that the request has been
denied. An RHC that is decertified from the RHC program due to failure
to meet the staffing requirements would no longer be eligible to
operate as an RHC. However, the RHC could apply to become a physician-
directed clinic, group practice, or a group of individual practitioners
who would then bill Medicare using the Part B fee-for-service system.
3. Contractual Arrangements
Due to the difficulty in recruiting and retaining physicians in
rural areas, RHCs have had the option of hiring physicians either as
RHC employees or as contractors. However, in order to promote stability
and continuity of care, the Rural Health Clinic Services Act of 1977
required RHCs to ``employ a physician assistant or nurse practitioner''
(section 1861(aa)(2)(iii) of the Act). We note that the term
``employee'' is defined in section 3121(d)(2) of the Internal Revenue
Code of 1986 and is usually evidence by the employer's provision of a
W-2 form to the employee. Our current regulations at Sec.
405.2468(b)(1) state that `` * * * (RHCs are not paid for services
furnished by contracted individuals other than physicians).''
In the more than 30 years since this legislation was enacted, the
health care environment has changed dramatically, and RHCs have
requested that they be allowed to enter into contractual agreements
with PAs and NPs as well as physicians. To provide RHCs with greater
flexibility in meeting their staffing requirements, we propose to
revise Sec. 405.2468(b)(1) by removing the parenthetical ``RHCs are
not paid for services furnished by contracted individuals other than
physicians.'' Also, we propose to revise Sec. 491.8(a)(3) to state
that nonphysician practitioners may furnish services under contract to
an RHC within the statutory limits.
RHCs would still be required, under section 1861(aa)(2)(iii) of the
Act, to employ a PA or NP. However, as long as there is at least one PA
or NP employed at all times (subject to the waiver provision set forth
at section 1861(aa)(7) of the Act), an RHC would be free to enter into
employment contracts with other PAs, NPs, or other nonphysician staff.
FQHCs already have the option to contract with PAs and NPs.
Authority to allow contracting for clinical services is provided for in
the PHS Act. The authority to allow Medicare participating FQHCs to
contract with any necessary health professional for the purpose of
treating their patients is further clarified by section 5114 of the
Deficit Reduction Act of 2005 (DRA) (Pub. L. 109-171) which amended
section 1842(b)(6) of the Act to require consolidated billing of
contracted professional services by adding new subsection (H) with the
following language: ``in the case of services described in section
1861(aa)(3) of the Act that are furnished by a health care professional
under contract with a Federally qualified health center, payment shall
be made to the center.'' Similar language regarding contracted medical
professionals was also added to section 1861(aa)(3) of the Act. FQHCs
and RHCs also have authority to claim the costs of such contracted
practitioners' services on the Medicare cost report to receive Medicare
payment.
A practitioner providing services under contract to the RHC or FQHC
should have a signed contract that includes his or her responsibilities
and requirements. All practitioners should be familiar with the clinic
or center's policies and procedures, and comply with the staffing
requirements in Sec. 491.8. Practitioners should be employed or
contracted to the RHC in a manner that enhances continuity and quality
of care.
We propose to remove the parenthetical statement at Sec.
405.2468(b)(1) which states that RHCs are not paid for services
furnished by contracted individuals other than physicians. We also
propose to revise Sec. 491.8(a)(3) to state that nonphysician
practitioners may furnish services under contract to an RHC.
C. Payment Issues
1. Payment Methodology for RHCs and FQHCs
Payment to RHCs and FQHCs for covered services furnished to
Medicare beneficiaries is made on the basis of an all-inclusive rate
per visit, subject to a payment limit. The Medicare Administrative
Contractor (MAC) or FI determines the all-inclusive rate in accordance
with this subpart and instructions issued by CMS.
With the exception of services provided under Medicare Advantage
plans to RHCs and FQHCs, the statutory payment requirements for RHC and
FQHC services are set forth at section 1833(a)(3) of the Act, (as
amended by the MMA), which states that RHCs and FQHCs are paid
reasonable costs ``* * * less the amount a provider may charge as
described in clause of section 1866(a)(2)(A), but in no case may the
payment exceed 80 percent of such costs[.]'' The beneficiary is
responsible for the Medicare Part B deductible
[[Page 36705]]
(except for services provided in FQHCs, where there is no Part B
deductible) and coinsurance amounts. Section 1866(a)(2)(A)(ii) of the
Act and implementing regulations at Sec. 405.2410(b) establish
beneficiary coinsurance at an amount not to exceed 20 percent of the
clinic's reasonable charges for covered services.
Section 237(c) of the MMA which pertains to cost sharing permitted
under MA organizations, revised section 1857(e) of the Act. These
changes were addressed in Sec. 405.2469 as part of the CY 2006
Physician Fee Schedule final rule with comment period (70 FR 70116).
In general, the statutory payment methodology requires that except
for services provided under MA plans to FQHCs in accordance with
section 1833(a)(3)(B) of the Act, RHCs and FQHCs subtract beneficiary
coinsurance and deductible amounts, as applicable (based on reasonable
charges) from reasonable costs to determine the Medicare payment. The
statute further stipulates that Medicare reimbursement may not exceed
80 percent of reasonable costs.
Until now, Medicare has been paying RHCs and FQHCs 80 percent of
the facility's reasonable costs, regardless of deductible and
coinsurance amounts billed to Medicare beneficiaries. This allowed RHCs
and FQHCs to receive, in some instances, payment in excess of 100
percent of reasonable costs.
Therefore, to conform existing regulations to the statutory payment
methodology described above, we propose to revise Sec. 405.2410 and
Sec. 405.2466(b)(1)(iii) by stipulating that, except for services
provided under MA plans to FQHCs, Medicare payment is equal to
reasonable costs less aggregate coinsurance and deductible amounts
billed, but in no case may total Medicare payment exceed 80 percent of
reasonable costs.
Note: Payment for the outpatient treatment of mental,
psychoneurotic, or personality disorders is subject to the
limitations on payment in Sec. 410.155
).2. Exceptions to the Per Visit Payment Limit
Prior to the BBA, the payment methodology for an RHC depended on
whether it was ``provider-based'' or ``independent.'' Payment to
provider-based RHCs for services furnished to Medicare beneficiaries
was made on a reasonable cost basis by the provider's FI in accordance
with our regulations at 42 CFR part 413. Payment to independent RHCs
for services furnished to Medicare beneficiaries was made on the basis
of a uniform all-inclusive rate payment methodology in accordance with
42 CFR part 405, subpart X. Payment to independent RHCs also was
subject to a maximum payment per visit as set forth in section 1833(f)
of the Act.
Section 4205(a) of the BBA amended section 1833(f) of the Act.
Under the BBA, the independent RHC all-inclusive payment methodology
and payment limit were applied to provider-based RHCs. This BBA
provision also provided an exception to the RHC payment limit for those
RHCs based in small, rural hospitals to help them remain financially
viable.
Section 224 of the Medicare, Medicaid, and SCHIP Benefits
Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554) enacted
on December 21, 2000, expanded to RHCs based in small, urban hospitals
the eligibility criteria for receiving an exception to the RHC payment
limit, effective July 1, 2001. This was implemented through a program
memorandum on December 6, 2001.
If an RHC is an integral and subordinate part of a hospital, it can
receive an exception to the per visit payment limit if the hospital has
fewer than 50 beds as determined by using one of the following methods:
The determination of the number of beds at Sec.
412.105(b); or
The hospital's average daily patient census count of those
beds described in Sec. 412.105(b), and the hospital meets all of the
following conditions:
++ It is a sole community hospital as determined in accordance with
Sec. 412.92 or Sec. 412.109(a).
++ It is located in a level 9 or 10 RUCA.
++ It has an average daily patient census that does not exceed 40.
The December 24, 2003 final RHC rule used the 1993 Urban Influence
Codes (UICs), then a 9-category measure developed by the U.S.
Department of Agriculture (USDA), to identify hospitals which are
located in sparsely populated rural areas. Hospitals with a level 8 or
9-level UIC and which have an average daily census of less than 50
patients would qualify for an exception to the RHC per visit payment
limit. The USDA has since changed the UICs to a 12-category measure,
with levels 9 through 12 comparable to the 1993 levels 8 and 9.
The UICs are a county-level measurement. Since many counties
encompass large geographical areas with significant variations in
population density, demographics, economics, and health care services,
the UICs do not always provide an accurate assessment of a local area's
degree of rurality.
The RUCA system is another method for identifying rural areas. RUCA
codes classify U.S. census tracts using measures of population density,
urbanization, and daily commuting. This classification uses 10 numbers
with subdivisions to reflect commuting flows.
RUCAs are used by CMS for purposes of determining rurality in the
hospital and ambulance payment systems. To target the needs of rural
populations more accurately and to be consistent with other CMS
programs, we propose to utilize the RUCA methodology instead of the UIC
methodology. We also propose that RUCA codes 9 and 10 be used for the
purpose of approving an exception to the per visit payment limit.
We propose to amend Sec. 405.2462 to provide payment to all RHCs
and FQHCs on the basis of an all-inclusive rate per visit, subject to
the per-visit payment limit. For a hospital-based RHC that is the
primary source of health care in its rural community as defined at
Sec. 412.92(a) or Sec. 412.109(a), we propose to utilize the
hospital's average daily census rather than bed count in determining
whether RHC services are subject to the per-visit payment limit. We
also propose to utilize RUCAs 9 and 10 to determine eligibility for an
exception to the per visit payment limit.
3. Commingling
Commingling refers to the sharing of RHC space, staff (employees or
contractors), supplies, records, and other resources with an onsite
Medicare Part B or Medicaid fee-for-service practice operated by the
same RHC physician(s) or nonphysician practitioner(s) or both.
Commingling is prohibited when it results in duplicate Medicare or
Medicaid reimbursement, either due to the inability of the RHC to
distinguish its actual costs from those that are reimbursed on a fee-
for-service basis, or due to other reasons.
An RHC and a Medicare fee-for-service practice may not operate
simultaneously in order to prohibit these shared practices from
selecting patient encounters for enhanced Medicare Part B billing.
However, an RHC that is part of a multipurpose clinic may house
other entities (such as private medical practices, x-ray and lab
clinics, dental clinics, emergency room) in the non-RHC space. The
entities occupying the non-RHC space may bill the assigned Medicare
Administrative Contractor (MAC), Fiscal Intermediary (FI), or carrier
as appropriate; authority is delegated to the MAC, FI, or carrier to
[[Page 36706]]
determine acceptable accounting methods for allocation of staff costs
between the RHC and other entities to be used in documenting allocation
of costs. Since in a multipurpose clinic the RHC may share some
resources in common with the non-RHC entity (for example, waiting room
or receptionist), the RHC must maintain accurate records to assure that
the RHC costs that it claims for Medicare reimbursement are only for
the staff, space, or other resources that are used for RHC purposes.
Any shared staff, space, or other resources must be allocated
appropriately between the RHC and non-RHC usage to avoid duplicate
reimbursement.
This commingling policy does not prohibit a hospital-based RHC from
sharing its health care practitioners with the hospital emergency
department in an emergency, or prohibit an RHC physician from providing
on-call services for an emergency room, as long as the RHC continues to
meet the RHC conditions for certification (CfCs) in the absence of the
practitioner(s) and the RHC is able to allocate appropriately the
practitioner's salary between RHC and non-RHC time.
Facilities are encouraged to work with their MAC, FI, or carrier
and RO in determining permissible resource-sharing situations and
proper cost reporting methods.
4. Payment for Services to Hospital Patients
The hospital inpatient bundling provision was enacted on April 20,
1983 in section 602(e)(3) of the Social Security Act Amendments of 1983
(Pub. L. 98-21), by adding paragraph (a)(14) to section 1862 of the
Act. The hospital outpatient bundling provision was enacted in section
9343(c) of OBRA '86, Public Law 99-509. Taken together, these two
provisions require bundling of the costs for all nonprofessional
services furnished to hospital patients. Consequently, section
1862(a)(14) of the Act now requires hospitals and CAHs to bundle all
costs, other than those for the professional services specified in the
statute.
Only professionals exempt from the hospital bundling provisions are
permitted to bill for services furnished to hospital patients. RHCs and
FQHCs cannot bill for services furnished by RHC practitioners to
hospital patients because RHC and FQHC services are not exempt from the
hospital bundling provisions.
Accordingly, any costs incurred by an RHC or FQHC associated with
the provision of services to hospital patients must be excluded from
RHC or FQHC allowable costs on their Medicare cost report. However, a
practitioner who provides services in an RHC or FQHC may, in some
cases, also have a private practice and be enrolled and qualified to
bill Medicare under that practice as a Part B practitioner. In these
situations, the practitioner may be able to bill Medicare Part B under
their private practice for covered services provided to hospital
patients.
Section 1862(a)(14) of the Act places restrictions on the payment
for services furnished to hospital and CAH patients. We propose to
revise Sec. 405.2411(b) and (c) to specify that RHC services are
covered when furnished in an RHC setting or other outpatient setting,
but are not covered when furnished in a hospital or CAH.
5. Payment for Services to Skilled Nursing Facility (SNF) Patients
Section 4432(b) of the BBA amended the statute to add a
consolidated billing provision for SNFs in section 1862(a)(18) of the
Act. Similar to the hospital bundling provision in section 1862(a)(14)
of the Act, this provision bundled all Part B services furnished to SNF
residents during a covered Part A stay into the SNF Prospective Payment
System (PPS) rates, except those services specifically excluded under
statute. RHC services were not among the excluded services. Although
the Congress excluded physician services and several other services
from the SNF bundle of services, RHC and FQHC services were not among
the services on the excluded under section 1888(e)(2)(A)(ii) of the
Act. Consequently, through program instructions to Medicare contractors
(PM A-99-8, March 1999), we announced that under the statute, RHC and
FQHC services furnished to SNF residents were subject to the SNF
consolidated billing provision and could not be billed to Medicare by
the RHC or FQHC.
However, section 410 of the MMA amended section 1888(e)(2)(A) of
the Act by adding a new paragraph (iv) to exclude RHC and FQHC services
from the SNF consolidated billing provision. This MMA change was
effective for services furnished on or after January 1, 2005. In
accordance with this section of the MMA, services included within the
scope of RHC and FQHC services described at section 1888(e)(2)(A)(ii)
of the Act are excluded from the SNF consolidated billing provision.
These services are limited to physician, PA, NP, CP, and CNM services.
Only this subset of RHC and FQHC services may be covered and paid
through the RHC and FQHC benefit when furnished to RHC and FQHC
patients in a Medicare Part A covered SNF stay. Payment for this subset
of services is made in the usual manner under the RHC and FQHC all-
inclusive payment methodology. All services other than physician, PA,
NP, CP, and CNM services that an RHC or an FQHC may furnish to a
patient in a Medicare covered Part A SNF stay are subject to the SNF
consolidated billing provision. This means any costs associated with
these other services are excluded from coverage and payment under the
RHC and FQHC benefit when furnished to a Part A SNF patient.
We propose to require in Sec. 405.2411(b) and (c) that payment for
RHC services furnished to patients at the RHC, at the patient's place
of residence, or at another facility other than a hospital or CAH, be
made to the RHC. As a result of the provisions in section 1862(a)(14)
of the Act, RHCs and FQHCs cannot bill for RHC or FQHC services
furnished by their practitioners to hospital or CAH inpatients.
6. Payment for Certain Physician Assistant Services
Sections 4511 and 4512 of the BBA removed the restrictions on the
types of areas and settings in which the Medicare Part B program pays
for the professional services of NPs, CNSs, and PAs. This provision
also expanded the professional services benefits for NPs and CNSs by
authorizing them to bill the program directly for their services when
furnished in any area or setting. However, these BBA provisions
maintained the current policy that payment for PA services can be made
only to the PA's employer regardless of whether the PA is employed
directly or is serving as an independent contractor.
Section 4205(d)(3)(B) of the BBA amended section 1842(b)(6)(C) of
the Act to provide that payment for PA services may be made directly to
a PA under certain circumstances. This provision permits Medicare to
directly pay a PA who is the owner of an RHC, as described in section
1861(aa)(2) of the Act, for a continuous period beginning before the
date of the enactment of the BBA and ending on the date the Secretary
determines the RHC no longer meets the requirements of section
1861(aa)(2) of the Act, for services furnished before January 1, 2003.
Section 222 of the BIPA amended section 1842(b)(6)(C) of the Act,
which permits PAs who owned RHCs and subsequently lost RHC status to
receive direct Medicare payment for their services, effective December
21, 2000. This BIPA provision eliminated the January 1, 2003 sunset
date. We propose
[[Page 36707]]
to revise Sec. 410.150(h)(15) and add Sec. 410.150(b)(20) to allow
PAs to receive direct Medicare payment for services provided by the
RHC, as long as the RHC continues to meet the requirements of section
1861(aa)(2) of the Act.
7. Screening Mammography
In June 2000 we released Program Memorandum A-00-30, which stated
that preventive physician and nonphysician services, such as screening
mammography, were covered when performed in an RHC/FQHC to the same
extent as other RHC/FQHC services. We propose to revise Sec. 405.2448
by removing paragraph (d), which states that screening mammography is
not considered a covered FQHC service.
8. Payment for High Cost Drugs
RHCs are reimbursed based on an all-inclusive payment methodology,
subject to an upper payment limit, which includes the cost of drugs
provided incident to a patient visit. We are aware that many RHCs would
like to provide services such as outpatient cancer treatments to their
patients, and that the patients would benefit from this service by not
having to travel greater distances to receive treatment elsewhere.
However, because drugs are included in the all-inclusive rate per
visit, it may not be financially viable for an RHC to provide
treatments that require high cost drugs for their patients.
We recognize the dilemma that RHCs may face in deciding whether to
provide certain treatments in the RHC that would benefit their patients
but may put their financial viability at risk. Therefore, we are
soliciting comments on this situation and possible solutions that can
be addressed through regulation or program guidance. Any possible
solution would need to take into account our legislative authority,
which does not generally allow reimbursement to RHCs for drugs, our
policy on commingling, and the need for administrative accountability.
D. Health and Safety, and Quality
1. Quality Assessment and Performance Improvement Program (QAPI)
Currently, each RHC is required to evaluate its total program
annually. The evaluation must include reviewing the utilization of the
clinic's services using a representative sample of both active and
closed clinical records, as well as reviewing the clinic's health care
policies. The purpose of the evaluation is to determine whether the
utilization of services was appropriate, the established policies were
followed, and if any changes are needed. The clinic's staff considers
the findings of the evaluation and takes the necessary corrective
action. These requirements focus on the meeting and documentation of
the clinic's evaluation of its quality care and do not account for the
outcome of these activities.
Section 4205(b) of the BBA amended section 1861(aa)(2)(I) of the
Act to authorize us to require that an RHC have a quality assessment
and performance improvement program (QAPI). Therefore, RHCs are
required by statute to have a QAPI program and it is a requirement for
certification as an RHC. Upon an initial or subsequent survey, an RHC
would be required to develop a plan of correction where a viable QAPI
program is not in effect.
A QAPI program enables the organization to systematically review
its operating systems and processes of care to identify and implement
opportunities for improvement.
Some RHCs have already incorporated a QAPI program into normal RHC
operating activities. For those which are starting to develop an
appropriate QAPI program, guidance and examples of QAPI-related
activities are available from professional and governmental
organizations, including some State offices of rural health.
HHS previously has contracted with the National Association of RHCs
(http://www.narhc.org) to develop technical assistance materials which
provide guidance for RHCs in complying with QAPI requirements. These
and other materials are available through HRSA's Office of Rural Health
Policy (http://www.ruralhealth.hrsa.gov). Information is also available
from the Rural Assistance Center (http://www.raconline.org), the
National Rural Health Association (http://www.nrharural.org), and the
Rural Policy Research Center (http://www.rupri.org). As it develops its
QAPI program, an RHC may find additional guidance through the
information contained in the Institute of Medicine report, ``Quality
Through Collaboration: The Future of Rural Health Care'', as well as
that contained at the database and Web site sponsored by the agency for
Healthcare Research and Quality, the National Quality Measures
Clearinghouse (http://www.qualitymeasures.ahrq.gov/). RHCs are
encouraged to take advantage of the resources available.
We would deem an RHC that chose to utilize a QAPI model program
provided by the Department (or other on-line resources mentioned in
this regulation) to have met the QAPI CfC, provided that the model
program chosen was one that was in compliance with the substantive
provisions of Sec. 491.11.
We propose to revise Sec. 491.11 to set forth explicit
requirements for a QAPI program. An RHC would set its own priorities
for performance improvement based on the prevalence and severity of
identified problems. The QAPI program would contain three standards
that would address: (1) Program components; (2) program activities; and
(3) program responsibilities.
The first standard, Sec. 491.11(a), would require that an RHC use
objective measures to evaluate organizational processes, functions and
services and the use of clinic services, including at least the number
of patients served and the volume of services.
The second standard, Sec. 491.11(b), would require RHCs to adopt
or develop performance measures that reflected processes of care and
RHC operation and were shown to be predictive of desired patient
outcomes or were the outcomes themselves. The RHC would have to use the
measures to analyze and track its performance. The RHC would set
priorities for performance improvement, considering high-volume, high-
risk services, the care of acute and chronic conditions, patient
safety, coordination of care, convenience and timeliness of available
services or grievances and complaints. Also, the RHC would have to
conduct distinct improvement projects and maintain records on its QAPI
program for each of the areas listed under the standard in Sec.
491.11(a). Additionally, a project to develop and implement an
information technology (IT) system explicitly designed to improve
patient safety and quality of care would be considered as meeting the
requirement for a QAPI project under this section. We are proposing
this IT provision because we believe that it is critically important
that RHCs identify opportunities to improve and expand the use of
information technology to prevent medical errors and improve quality of
care. This Administration is committed to working with other public and
private stakeholders to develop means for improving and expanding the
use of IT (such as computerized patient records). We encourage RHCs, as
they assess their organizational processes, functions, and services, to
identify opportunities and make use of information technologies. We
believe that the effective use of IT systems could prove invaluable to
improving the quality and safety of patient care over time. We would
allow RHCs to receive QAPI recognition for undertaking programs of
investment and development of IT systems that are
[[Page 36708]]
designed to result in improvements in patient safety and quality of
care as an alternative to other performance improvement projects (see
Sec. 491.11(b)(4)). In recognition of the time and resources required
to implement these IT programs, we would not require associated
activities to have a demonstrable benefit in the initial stages, but
would expect that the quality improvement goals and the associated
achievements would be incorporated in the plans for these programs.
The third proposed standard, Sec. 491.11(c), would require that
the RHCs professional staff, administrative officials, and governing
body (if applicable) ensure that there is an effective QAPI plan that
addresses identified priorities.
2. Infection Control
While the physical plant and environment standard in Sec.
491.6(a)(3) requires that RHCs and FQHCs keep the premises clean and
orderly, there is no current Medicare standard addressing infection
control in RHCs and FQHCs. We believe that RHCs and FQHCs should be
required to have infection control guidelines and an implementation
plan. The value of infection control measures in reducing infectious
and communicable diseases long has been recognized, and we realize that
a large number of clinics and centers may be implementing some aspects
of an infection control program. However, because of the real and
potential hazards which infectious and communicable diseases present,
we believe that it would be prudent to add a formal standard requiring
adherence to infection control guidelines that have been recognized by
industry standards and regulatory bodies as being appropriate for
facilities such as RHCs and FQHCs. The Association for Professionals in
Infection Control and Epidemiology (APIC) and the Society for
Healthcare Epidemiology of America (SHEA), in their October 1999
Consensus Panel Report, stated that infection prevention and control
issues are important throughout a continuum of care, including
physicians' offices, clinics, ambulatory surgical centers, and in
individuals' homes through home health agencies. Likewise, a Centers
for Disease Control (CDC) article, entitled ``Health-Care Quality
Promotion, through Infection Prevention: Beyond 2000''; Vol. 7, No. 2,
March-April 2001, by Julie Louise Gerberding, reported that the urgent
need for enhanced infection prevention programs in nonhospital settings
has been acknowledged for more than a decade. However, programs
designed to effectively address this need have been slow to evolve. One
contributing factor offered in the article was a lack of regulatory and
accreditation standards to ensure that truly effective program
components are in place.
We agree with the CDC's findings as well as with the intent of the
article, and are proposing that the new infection control standard
place accountability on RHCs and FQHCs to prevent and control
infectious and communicable diseases, and to take actions that result
in improvements to infection control practices.
We are proposing to add, under Sec. 491.6, a new paragraph (d)
that would require RHCs and FQHCs to have infection control guidelines
and an implementation plan. Model guidelines are available from various
professional organizations, and RHCs and FQHCs would have flexibility
in determining how best to meet these objectives. For example, RHCs and
FQHCs would determine how much staff training in infection control
would be necessary, the method of oversight, and the appropriate level
of documentation that would be required. However, we do expect that RHC
and FQHC staff engaged in direct patient care would follow current
accepted standards of infection control practice (for example, wearing
gloves when handling blood or blood products, and following hand
hygiene guidelines). We believe that if a clinic or center currently
complies with the infection control standards of the industry for
outpatient health care facilities, then they would most likely meet or
exceed this proposed standard. The infection control activities should
be an integral part of the RHCs or FQHCs overall QAPI program and the
FQHCs quality improvement program as also required by section
330(k)(3)(C) of the PHS Act, and should be addressed in these programs
on an ongoing basis.
3. Hours of Operation
a. Posting of Hours
RHCs and FQHCs have varying hours and days of operation based on
staff and anticipated patient load. Beneficiaries in rural areas often
travel long distances to obtain services. Therefore, we are proposing
to require under Sec. 491.6(e) that an RHC or FQHC must post at or
near the entrance to the facility a sign that states the days of the
week and hours when RHC or FQHC services are furnished. This
information would have to be displayed in a manner so that it can be
viewed easily by persons who have vision problems and who are in
wheelchairs.
b. Use of the RHC Facility
Section 491.8(a)(6) states that a RHC must have a physician, NP,
PA, CNM, CSW, or CP available to furnish patient care services at all
times the RHC operates, and that an NP, PA, or CNM must be available to
furnish patient care services at least 50 percent of the time the RHC
operates.
To provide RHCs with flexibility to allow access patients to enter
the RHC for purposes other than patient care while complying with the
requirements of Sec. 491.8(a)(6), we are clarifying that RHCs may
allow patients to enter the waiting room or other areas not utilized
for patient care when the premises are opened solely to address
administrative matters, or to allow patients entry into the building to
get out of inclement weather. The RHC would not be considered ``in
operation'' as an RHC during these periods. No health care services
would be provided until a physician, NP, PA, CNM, CSW, or CP was
present to provide such services. RHCs that choose to exercise this
flexibility should post the hours they offer administrative services
only versus the hours they offer RHC health care services. The signage
which would be required by Sec. 491.6(e) should clearly delineate the
times the NP, PA, CNM, CSW, CP, or physician was present and the RHC
would be in operation and providing health care services. If State law
does not allow access to the RHC premises when the RHC is not in
operation as an RHC, the facility must adhere to State law.
4. Emergency Services and Training
We propose to revise Sec. 491.9(c)(3) to reflect current industry
standards and procedures for first responses to common life-threatening
injuries and acute illnesses. We would expect that clinical personnel
responding to emergencies would assess and stabilize sick or injured
persons and administer emergency medical treatment while waiting for
emergency transport to arrive or until such time that the patient could
receive an advanced level of care.
RHCs and FQHCs would continue to be required to provide medical
emergency procedures as a first response to common life-threatening
injuries and acute illness and to have available the drugs and
biologicals commonly used in lifesaving procedures. Even though we are
proposing to retain the language in the requirement regarding the
availability of drugs and biologicals, we propose to eliminate the
prescriptive list of those drugs and biologicals that is currently
required. In addition to the drugs and
[[Page 36709]]
biologicals that currently are required, we propose that a clinic or
center also have available commonly used equipment and supplies for
emergency first response procedures that are appropriate for its
patient population. Since the proposed conditions are outcome-oriented,
we do not believe that we need to specify all the equipment and
supplies that a facility should have to accommodate the emergency
medical needs of a clinic or center's patients. However, we would
expect a clinic or center to have the emergency equipment and supplies
that are commonly found in a physician's office or a clinic.
Appropriate drugs, biologicals, equipment, and supplies that one would
expect to find in a clinic providing emergency first response
procedures might include those items that are normally found in an
emergency medical crash cart. We believe that most, if not all, clinics
and centers would already have these types of supplies in order to
provide the emergency services required under the current regulations.
Although we are not specifically proposing to require
defibrillators at this time, studies have shown that the appropriate
use of defibrillators can save lives. In particular, automated external
defibrillators (AEDs) have been shown to save lives in a variety of
settings. The key to saving a life is getting the defibrillator on the
patient as soon as possible. According to the American College of
Emergency Physicians article entitled ``Automatic External
Defibrillators,'' June 2003 (http://www.acep.org/12891.0.html), when a
person suffers a sudden cardiac arrest, the chance of survival
decreases by 7 to 10 percent for each minute that passes without
defibrillation. The potential for saved lives supports the financial
investment in an AED. Currently, the cost of an AED is approximately
$2,000 to $3,000. We are soliciting comments on whether AEDs should be
made a regulatory requirement in the future, since RHCs and FQHCs can
be located in remote and frontier areas where advanced emergency care
might not be available in time to prevent cardiac complications or
death.
We also are proposing that staff receive training in the provision
of the RHCs or FQHCs emergency procedures. The current requirement does
not address this issue. Primary care providers such as physicians,
nurse practitioners, physician assistants, nurses, and other allied
health personnel often do not frequently receive opportunities to
participate in a wide range of emergency care procedures, and,
therefore, can benefit from training. At a minimum, we would expect
that these professionals are trained in basic life support (BLS). The
American Heart Association's (AHA's) guidelines for health care
provider courses state that its BLS course teaches the skills of
cardiopulmonary resuscitation (CPR) (including ventilation with a
barrier device, a bag-mask device, and oxygen) for victims of all ages,
and the use of an AED. The course is designed for health care providers
that care for patients in a wide variety of settings, both in and out
of a hospital.
This basic training may also be augmented by the clinic or center
through a variety of means. For example, a facility may elect to
provide its own in-service training in emergency procedures or it may
choose to use outside resources such as basic trauma life support
(BTLS), advanced cardiac life support (ACLS), and pediatric advanced
life support (PALS) courses. We encourage clinics and centers to take
advantage of these and other existing resources as they determine
training needs of personnel providing care to patients.
Additionally, as proposed in Sec. 491.9(c)(3)(iii), a clinic or
center would be required to provide training for staff. Because a
midlevel practitioner is required to be available to furnish patient
care at all times the RHC or FQHC operates, we do not expect the
nonprofessional staff to be responsible for providing first response
emergency care. However, these individuals would need to be trained in
accordance with the facility's policies and procedures related to their
roles during the provision of emergency medical services by
professional staff. We would expect facilities to determine the best
way to train these personnel according to the facilities' individual
needs. Facilities may elect to use outside resources such as the AHA's
Heartsaver First Aid course, which combines first aid, adult CPR, and
AED training, in-service training through the clinic or center's
professional staff, or a combination of both. Each facility would be
expected to develop its own emergency strategies which are consistent
with commonly accepted practice and to document such plans in its
written policies.
5. Patient Health Records
RHCs and FQHCs are required to maintain a medical record for each
patient receiving health care services. To update patient health record
requirements to reflect technological advances in how physicians or
other health care professionals sign and authenticate their signatures,
we are proposing to update the medical records requirement at Sec.
491.10(a)(3) for RHCs and FQHCs to reflect our requirements and
guidelines for other participating providers regarding electronic
medical records and electronic signatures.
We propose at Sec. 491.10(a)(3)(v) that all entries (electronic or
manual) in the medical record must be legible, complete, dated, timed,
and authenticated promptly in written or electronic form by the person
responsible for ordering, providing, or evaluating the service
furnished. We are also proposing that any entry in the patient health
record must be identified and authenticated promptly by the person
making the entry. In addition, we are proposing that all entries in the
patient health record must be authenticated within 48 hours unless
there is a State law that designates a specific timeframe for the
authentication of entries.
The identification may include signatures, written initials, or
computer entry. If rubber stamp signatures are authorized, the
individual whose signature the stamp represents must place in the
administrative offices of the RHC or FQHC a signed statement to the
effect that he or she is the only individual authorized to use the
stamp and may not delegate the stamp to another individual. A list of
computer or other codes and written signatures must be readily
available and maintained under adequate safeguards. When rubber stamps
or electronic authorizations are used for identification, the RHC must
have policies and procedures in place to ensure that stamps or
authorizations are used only by the individuals whose signature they
represent.
Inherent in these proposed requirements is the idea that there be a
specific action by the author to indicate that entries are verified and
accurate. Examples of such authentication of entries include: a
computerized system that requires the physician to review the document
on-line and indicate that it has been approved by entering a computer
code; a system in which the physician signs off against a list of
entries that must be verified in the individual record; or a mail
system in which transcripts are sent to the physician for review, after
which he or she signs and returns a postcard identifying the record and
verifying its accuracy.
A system of auto-authentication in which a physician or other
practitioner authenticates a report before transcription is not
consistent with these proposed requirements. There
[[Page 36710]]
must be a method of determining that the practitioner in fact did
authenticate the document after it was transcribed.
E. Other Proposed Changes
1. General
In addition to the regulatory changes previously described, we
propose the following:
Adding the definition of ``nurse practitioner (NP)'' and
``physician assistant (PA)'' to Sec. 405.2401(b) and removing the
definitions from Sec. 491.2 so that RHC/FQHC-related provider
definitions are located in the same regulatory section (with the
exception of clinical psychologist, which continues to be defined in
Sec. 405.2450.)
Adding the word ``certified'' to the definition of
``nurse-midwife'' in Sec. 405.2401(b) and Sec. 405.2414 to conform to
statutory language in sections 1861(aa) and (gg)(2) of the Act.
Adding the definition of ``clinical social worker'' (CSW)
to Sec. 405.2401(b). The definition of ``covered RHC services'' was
extended to include the services of a CSW but the definition of a CSW
has not been added to the regulations.
Revising the definition of ``Federally qualified health
center'' (FQHC) in Sec. 405.2401(b) to conform the regulations to
current statutory requirements.
Revising the definition of ``rural health clinic'' to
Sec. 405.2401(b) and removing the definition from Sec. 491.2 so that
it conforms with statutory language in section 1861(aa)(2) of the Act.
Revising references to the ``Secretary'' in Sec. 405.2404
and Sec. 491.2 to incorporate gender-neutral language.
Adding the phrase ``CNM, CP, CSW services and supplies''
to Sec. 405.2411 and Sec. 405.2415 to conform to statutory changes in
section 1861(aa)(1)(B) and section 1861(aa)(2)(J) of the Act.
Making additional revisions to Sec. 491.3 to implement
proposed certification procedures, in conjunction with the proposed
changes to the designation process previously described.
Revising the heading and introductory text of Sec. 491.4
to make it consistent with the comparable CoP provisions for hospitals
and most other providers and to emphasize that the requirements of
primary concern are State licensure laws.
2. FQHCs
Section 5114 of the DRA makes a technical correction to section
1861(aa)(4)(A) of the Act by striking the phrase ``(other than
subsection (h))'' from that clause. This section of the statute
identifies the types of health centers receiving funding under section
330 of the PHS Act that are eligible for Medicare FQHC status. Section
330(h) of the PHS Act, to which the clause refers, addresses Healthcare
for the Homeless Health Centers. We are conforming our regulations at
Sec. 405.2401 to recognize Healthcare for the Homeless Health Centers
as Medicare FQHCs. We also are taking this opportunity to delete
obsolete references to sections 329 and 340 of the PHS Act.
III. Collection of Information Requirements
Under the Paperwork Reduction Act (PRA) of 1995, we are required to
provide 60-day notice in the Federal Register and solicit public
comment when a collection of information requirement is submitted to
the OMB for review and approval. In order to evaluate fairly whether
OMB should approve an information collection, section 3506(c)(2)(A) of
the PRA requires that we solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
Therefore, we are soliciting public comment on each of these issues
for the information collection requirements (ICRs) discussed below.
A. ICRs Regarding Location of Clinic (Sec. 491.5)
Proposed Sec. 491.5(b) states that an RHC may be granted an
exception to the location requirement specified in Sec. 491.5(a)(1) if
the clinic meets the requirements listed in Sec. 491.5(b)(1) through
(3). Section 491.5(b)(3) states that an RHC may be granted an exception
to the location requirements if it meets the essential provider
criteria that are outlined in Sec. 491.5(c). As stated in Sec.
491.5(c), CMS grants essential provider status for a period of 3-years.
However, a clinic may reapply for essential provider status if it still
needed the exception. An RHC must furnish documentation to demonstrate
its compliance with one of the conditions listed in Sec. 491.5(c)(1)
through (4).
The burden associated with these proposed requirements is the time
and effort necessary for an RHC to submit an application to CMS for an
exception to the location requirement. As part of the application, the
RHC must collect and submit to CMS the necessary information to support
its claim that it meets one of the essential provider criteria listed
in Sec. 491.5(c)(1) through (4). We estimate that it would take each
RHC 10 hours to collect and submit the necessary information to CMS.
The total estimated annual burden associated with this requirement is
5000 hours.
Section 491.5(e)(7) states that at the conclusion of the 3-year
exception period, an RHC may renew its essential provider status. The
RHC must submit written assurances to the appropriate CMS regional
office that it continues to meet the conditions specified in Sec.
491.5. The burden associated with this proposed requirement would be
the time and effort necessary to submit written assurances to the
appropriate CMS regional office.
We estimate that a total of 500 RHCs would be subject to the
requirements contained in Sec. 491.5(e)(7). We estimate that it would
take each of the 500 RHCs 1 hour to submit the necessary information to
CMS. The estimated annual burden is 500 hours.
B. ICRs Regarding Physical Plant and Environment (Sec. 491.6)
Proposed Sec. 491.6(d) states that RHCs and FQHCs must protect
their patients and staff members by maintaining and documenting an
infection control process. The burden associated with this proposed
requirement is the time and effort necessary to establish, maintain,
and document the infection control process that meets the requirements
listed in Sec. 491.6(d)(1) and (2). While these requirements are
subject to the PRA, the associated burden is exempt as stated in 5 CFR
1320.3(b)(2). Establishing, maintaining and documenting an infection
control program and processes are usual and customary business
practices. In addition, maintenance of a documented infection control
program is required as part of quality assessment and performance
improvement (QAPI) program. The total burden associated with QAPI
program requirements is discussed later in Section III.E of the
collection of information section of this regulation.
Section 491.6(e) would require clinics or centers to post signs
that are noticeable and can be viewed by those with vision problems and
those in wheelchairs. The signs must be located at or near the front of
the facility. The purpose of the signs is to advise the public of the
hours of operation for the center or clinic. The burden associated
[[Page 36711]]
with this reporting requirement is the time and effort necessary to
create signs and post the signs for the public. While this requirement
is subject to the PRA, we believe that the associated burden is exempt
as stated in 5 CFR 1320.3(b)(2); posting the signs containing the hours
of operation is a usual and customary business practice.
C. ICRs Regarding Staffing and Staff Responsibilities (Sec. 491.8)
Proposed Sec. 491.8(d) states that a qualified RHC can request a
temporary staffing waiver. If the request is approved, the waiver is in
effect for a 1-year period. As stated in Sec. 491.8(d)(1), to request
a waiver the RHC must demonstrate that it has been unable, despite
reasonable efforts in the previous 90-day period, to hire a certified
nurse-midwife, nurse practitioner, or physician assistant to furnish
services at least 50 percent of the time the RHC provides clinical
services. The burden associated with this proposed requirement is the
time and effort necessary for an RHC to demonstrate to CMS it has been
unable to meet the RHC staffing requirements. We estimate that 100 RHCs
would apply for waivers on an annual basis. We believe that it would
take 3 hours for each RHC to draft its waiver request and demonstrate
its inability to meet the staffing requirements. We estimate the total
annual burden to be 300 hours.
Proposed Sec. 491.8(d)(3) states that an RHC may submit a request
for an additional waiver of staffing requirements no earlier than 6
months after the expiration of the previous waiver. The burden
associated with this proposed requirement is the time and effort
necessary to submit an additional waiver request. The burden associated
with this requirement is explained in our discussion of proposed Sec.
491.8(d)(1).
D. ICRs Regarding Patient Health Records (Sec. 491.10)
Proposed Sec. 491.10 states that an RHC or an FQHC must maintain a
record for each patient receiving health care services. The record must
include legible entries that are completed, dated, timed, and
authenticated promptly in written or electronic form by the person
responsible for ordering, providing, or evaluating the service. All
entries in the patient health record must be authenticated within 48
hours unless there is a State law that designates a specific timeframe
for the authentication of entries.
The burden associated with these proposed requirements is the time
and effort necessary to maintain a patient record. This burden includes
the time necessary to record complete, legible entries and to
authenticate the record. While these requirements are subject to the
PRA, the associated burden is exempt under 5 CFR 1320.3(b)(2).
Maintaining and authenticating patient health records is part of usual
and customary business practices. As stated in 5 CFR 1320.3(b)(2), the
time, effort, and financial resources necessary to comply with a
collection of information that would be incurred by persons in the
normal course of their activities is exempt from the PRA.
E. ICRs Regarding Quality Assessment and Performance Improvement (Sec.
491.11)
Section 491.11 would require an RHC to develop, implement,
evaluate, and maintain an effective, ongoing, data-driven quality
assessment and performance improvement (QAPI) program. As part of the
QAPI program, Sec. 491.11(b)(1)(i) requires an RHC to adopt or develop
performance measures that reflect processes of care and RHC operations.
Section 491.11(b)(1)(ii) further requires that the RHC use the measures
to analyze and track its performance.
Proposed Sec. 491.11(b)(3) states that an RHC must conduct
distinct improvement projects. The number and frequency of the distinct
improvement projects must reflect the scope and complexity of the
clinic's services and available resources. In addition, Sec.
491.11(b)(5) states that an RHC must maintain records on its QAPI
program and quality improvement projects.
The burden associated with this proposed requirement would be the
time and effort necessary for the RHC to maintain records on its QAPI
and quality projects. We estimate that it will take each clinic 1 hour
per year to meet this requirement. Since there are an estimated 3,700
facilities, the total burden associated with this requirement would be
3,700 annual hours. The burden associated with this requirement is
currently approved under OMB 0938-0334.
The burden associated with all of the proposed requirements in
Sec. 491.11 is the time and effort necessary for an RHC to develop,
implement, evaluate, and maintain a QAPI program. We estimate that it
would take each of the 3,700 facilities 40 hours to comply with the
requirements in Sec. 491.11. We estimate a one-time annual burden of
148,000 to develop a QAPI program.
Table 1.--Estimated Annual Reporting and Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Total annual
Regulation section(s) OMB control number Respondents Responses burden
(hours)
----------------------------------------------------------------------------------------------------------------
Sec. 491.5(c)....................... 0938-New................ * 500 500 5,000
Sec. 491.5(e)(7).................... 0938-New................ *500 500 500
Sec. 491.8(d)....................... 0938-New................ 100 100 300
Sec. 491.11......................... 0938-0334............... 3,700 3,700 ** 148,000
-----------------------------------------------
Total............................. ........................ 4,300 4,300 153,800
----------------------------------------------------------------------------------------------------------------
* The same 500 respondents are subject to the requirements in both Sec. 491.5(c) and Sec. 491.5(e)(7). They
are only counted once in our burden estimate.
** Estimated one-time annual burden.
If you comment on these information collection and recordkeeping
requirements, please mail copies directly to the following: Centers for
Medicare & Medicaid Services, Office of Strategic Operations and
Regulatory Affairs, Regulations Development Group, Attn.: William N.
Parham, III (Attn: CMS-1910-P2) Room C4-26-05, 7500 Security Boulevard,
Baltimore, MD 21244-1850; and Office of Information and Regulatory
Affairs, Office of Management and Budget, Room 10235, New Executive
Office Building, Washington, DC 20503, Attn: Carolyn Lovett, CMS Desk
Officer, CMS-1910-P2, Carolyn_Lovett@omb.eop.gov. Fax (202) 395-6947.
[[Page 36712]]
IV. Regulatory Impact Analysis
A. Overall Impact
We have examined the impacts of this rule as required by Executive
Order 12866 (September 1993, Regulatory Planning and Review), the
Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354),
section 1102(b) of the Act, the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4) (UMRA), Executive Order 13132 on Federalism, and the
Congressional Review Act (5 U.S.C. 804(2)).
Executive Order 12866 (as amended by Executive Order 13258, which
merely reassigns responsibility of duties) directs agencies to assess
all costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). A
regulatory impact analysis (RIA) must be prepared for major rules with
economically significant effects ($100 million or more in any one
year).
The RFA requires agencies to analyze options for regulatory relief
of small businesses. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and government
jurisdictions. Most hospitals and most other providers and suppliers
are small entities, either by nonprofit status or by having revenues of
$6 to $29 million or less annually (see 65 FR 69432). For purposes of
the RFA, all RHCs and FQHCs are considered to be small entities.
Individuals and States are not included in the definition of a small
entity.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 603 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a Core-Based
Statistical Area and has fewer than 100 beds. We are not preparing an
analysis for section 1102(b) of the Act, because we have determined
that this proposed rule would not have a significant impact on the
operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4) (UMRA) requires that agencies assess anticipated costs and
benefits before issuing any rule that may result in an expenditure in
any one year of $120 million in the aggregate by State, local, or
tribal government, or by the private sector. This proposed rule would
not mandate any new requirements for State, local or tribal
governments, and private sector costs are expected to be less than the
$120 million threshold.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct compliance costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. The proposed rule would not have a substantial effect on
State and local governments.
Although we view the anticipated results of these regulations as
beneficial to the Medicare and Medicaid programs as well as to Medicare
beneficiaries and Medicaid recipients, and State governments, we
recognize that some of the provisions could be controversial and may be
responded to unfavorably by some affected entities. We also recognize
that not all of the potential effects of these provisions can be
anticipated definitely, especially in view of the interaction with
other Federal, State, and local activities regarding outpatient
services. In particular, considering the effects of our simultaneous
efforts to improve the delivery of outpatient services, it is
impossible to meaningfully quantify a projection of the future effect
of all of these provisions on RHCs' and FQHCs' operating costs or on
the frequency of substantial noncompliance and termination procedures.
We believe that this regulation would not have a significant
financial impact on a substantial number of small entities, such as
RHCs and FQHCs. This analysis, in combination with the rest of the
preamble, is consistent with the standards for analysis set forth by
the RFA.
B. Anticipated Effects
1. Effects of the Location Requirements on Rural Health Clinics
There are approximately 3,705 participating RHCs. Of these,
approximately 500 no longer meet the location requirements for either
because they are not in an area designated by the U.S. Census Bureau as
nonurban, or they are not designated by the Health Resources and
Services Administration as an eligible shortage area. Participating
RHCs that no longer are located in rural, underserved areas could lose
RHC status and related cost-based reimbursement, potentially causing
them to reduce services or discontinue serving Medicare beneficiaries.
The estimated Medicare savings associated with the decertification of
certain RHCs from the Medicare program are not considered significant.
To minimize the impact of this provision on rural health care,
however, the Congress has authorized us to grant, if needed, an
exception to clinics determined to be essential to the delivery of
primary care in these affected areas. Section 491.5 proposes criteria
to determine if an RHC qualifies for an exception to the location
requirements. An RHC that is no longer in a valid shortage or is in an
urban area may apply for exception from RHC location requirements.
Most, but not all, RHCs that apply for an exception are expected to
qualify, and would not be decertified based on the location
requirements.
Section 4205 of the BBA amended section 1833(f) of the Act to
require that provider-based RHCs are subject to the same payment
methodology as independent RHCs. Before the BBA, payment to provider-
based RHCs was made without considering the number of patient visits
provided by the RHC and without a limit on the payment per visit. This
already has been implemented through manual instructions and has helped
to establish payment equity and consistency within the RHC program. We
have codified the statutory requirement to pay all RHCs under an all-
inclusive rate per visit, which avoids allocation of excessive
administration costs to RHCs, and allow exceptions to the per-visit
payment limit for qualifying RHCs.
We believe the fiscal impact of limiting the provider-based RHC
payment to the independent RHC rate per visit has resulted in program
savings. Provider-based RHCs that have costs above the all-inclusive
cost-per-visit limit required by the law may have experienced some
decrease in current reasonable cost basis payments. To reduce
detrimental impacts of this decrease, section 4205 of the BBA permits
an exception to the upper payment limit for RHCs based in small
hospitals of less than 50 beds. The number of beds is determined
according to the definitions established in Sec. 412.105(b), or an
alternative definition established in a Program Memorandum issued
September 30, 1998, and updated on December 6, 2001. The alternative
bed definition states that a hospital-based RHC can receive an
exception to the per visit payment limit if its hospital has fewer than
50 beds as determined by the hospital's average daily census count, is
a sole community hospital
[[Page 36713]]
located in a level 9-12 UIC, and has an average daily census that does
not exceed 40.
There are currently 909 provider-based RHCs whose parent hospital
has fewer than 50 beds. Of these, 354 are in UICs 9-12 and are
therefore eligible for the exception to the per visit payment limit. By
changing to the more accurate RUCAs, approximately 100 of these RHCs
would no longer be eligible for the exception to the per-visit payment
limit, but 251 previously ineligible RHCs would be eligible. This would
result in a net total of 505 RHCs eligible for the exception to the per
visit payment limit, a gain of 151. We expect that the RHCs that would
gain eligibility to the payment limit exception would be in more rural
areas that have greater financial challenges. Therefore, the fiscal
impact of this change is expected to be minimal.
The QAPI requirement may increase burden in the short term because
resources currently used for the required evaluation of the clinic's
programs would need to be directed to the development of a QAPI program
that covers the complexity and scope of the particular clinic. Although
the requirements may result in some immediate costs to an individual
clinic, we believe that the QAPI program would result in real, but
difficult to estimate, long-term economic benefits to the clinic (for
example, cost-effective performance practices or higher patient
satisfaction that may lead to increased patient visits for the clinic).
Further, the QAPI and utilization review requirements replace the
current annual evaluation requirement. Resources that the clinics
currently are using for the annual evaluation could be devoted to the
QAPI program. Therefore, we believe that there would be no long-term
increased burden on the clinics. Currently, a number of RHCs, primarily
provider-based, have some type of quality improvement program in place.
To the extent that a clinic is familiar with collecting data on its
operations and measuring quality, the new requirement should not impose
significant additional burden.
2. Impact of the QAPI Provisions
We estimate that the additional one-time impact for the initial
development of the QAPI provisions would be as Shown in Table 2.
Table 2
------------------------------------------------------------------------
Hours/estimated salary/number of RHCs One-time Cost Annual cost
------------------------------------------------------------------------
1 physician/administrator at $58/hr x 3 $574,200 ..............
hrs x 3,300 clinics for medical
direction and overview of QAPI program.
1 Mid-level practitioner (physician 2,956,800 ..............
assistant, nurse practitioner) at $28/
hr x 32 hrs x 3,300 clinics for program
development............................
1 clerical staff at $6/hr x 5 hrs x 99,000 ..............
3,300 clinics..........................
1 mid-level practitioner at $28/hr x 4 .............. 369,600
hrs x 3,300 clinics for data collection
and analysis...........................
1 mid-level practitioner--3 hrs training .............. 277,200
-------------------------------
Totals.............................. 3,630,000 646,800
------------------------------------------------------------------------
To develop our estimates, we used information on the salaries and
wage estimation obtained from the American Medical Association.
OBRA '89 reduced the nonphysician staffing requirement for RHC
qualification from 60 percent to 50 percent. This reduction should have
a positive effect on RHCs by providing them more flexibility in
satisfying overall staffing needs.
3. Effects on Other Providers
We are aware of situations in which an RHC and a physician's
private practice occupy the same space and bill Medicare for services
either as an RHC or as a physician, depending upon which payment method
produces the greater payment. Our revision would require an RHC to be a
distinct entity that is not used simultaneously as a private physician
office or the private office of any other health care professional. As
a result, private physicians or other practitioners who have used this
approach under the Medicare program may experience some change in the
operation of their practices from an administrative standpoint.
4. Effects on the Medicare and Medicaid Programs
As a result of this proposed rule, some existing RHCs would be at
risk of losing their RHC status. We believe that any aggregate changes
to overall spending would be negligible. This proposed rule would also
result in some RHCs losing their exception to the per visit payment
limit, while other RHCs would become eligible for the exception to the
per visit payment limit. We cannot estimate accurately the payment
differential since the clinics vary in terms of size and patient
visits.
However, we believe that since total expenditures for this program
represent a small fraction of the Medicare and Medicaid total budget
and less than 20 percent of all RHCs would experience changes to
payment rates, any aggregate savings would be insignificant. We also
believe an insignificant amount of Medicare and Medicaid program
savings would result from the provision that would terminate RHC status
for certain providers. An RHC that loses its eligibility to participate
in the RHC program likely would choose to participate in the Medicare
and Medicaid programs in a non-RHC capacity such as a physician-
directed clinic or a group of individual practitioners who would then
bill Medicare using the Part B fee-for-service system.
C. Alternatives Considered
Section 4205 of the BBA imposes new requirements that the RHC
program must meet. We considered some of the following alternatives to
implement these provisions:
1. ``Essential'' RHCs
Since the statute mandates an exception process for essential
clinics, we considered using a national utilization test to recognize
clinics that are accepting and treating a disproportionately greater
number of Medicare, Medicaid, and uninsured patients in comparison to
other participating RHCs, for the purpose of addressing the situation
of RHC clusters. For example, using an aggregate threshold based on the
average Medicare, Medicaid, and uninsured utilization rates of
participating RHCs, an applicant would have to demonstrate that its
utilization rates exceed the threshold.
Although this test would be administratively feasible, we
concluded, based on our analysis of available Medicare and Medicaid RHC
data, that it would not determine accurately
[[Page 36714]]
``essential'' clinics at the community level because of the wide
variability in the percentage of services furnished to Medicare and
Medicaid patients by RHCs. Despite our rejection of a national
utilization test, we are open to suggestions on developing a minimum
national percentage, which could be integrated with our major community
provider test. We also considered the option of establishing less
generous tests for identifying RHCs as essential clinics to the
delivery of primary care. That is, we considered the establishment of
tests narrowly focused on a few extreme cases, such as an exception
test for only sole community providers. We rejected this option because
of concern that the decertification of a clinic from the RHC program
could decrease access to primary care for the entire community. We
believe several options should be available to reflect the variability
of communities in providing access to care for rural areas.
2. QAPI Program
Because the statute mandates that an RHC have a QAPI program, and
appropriate procedures for review of utilization of clinic services, no
alternatives for the requirement were considered. However, in the
preamble of the February 28, 2000, proposed rule, we described
alternative ways of satisfying the ``minimum level requirement'' for
the QAPI program and requested public comment. We considered the
following alternatives:
Require RHCs to engage in an improvement project in three
specified domains annually.
Require a minimum number of improvement projects in any
combination of the specified domains annually.
Require a minimum number of projects annually based on
patient population.
Rather than requiring a minimum number of projects,
require RHCs to demonstrate to the State Survey Agency what projects
they are doing and what progress is being achieved.
After considering the public comments, which were not conclusive,
we decided not to establish a minimum requirement. As we noted in the
December 24, 2003, final rule, we did consider alternatives for the
rule. One alternative was to take a more rigid approach, whereby the
final rule would be more prescriptive in the process that RHCs must
follow to develop the QAPI program, to include setting forth specific
performance measures to be used, the frequency and number of QAPI
``interventions'' that must be done, and the type and frequency of data
to be collected. While a more rigid approach would increase RHC burden,
we realize there would be no assurance that it would result in better
or more predictable outcomes.
We decided to promote a more flexible and less prescriptive
approach to the QAPI condition. We are more concerned with an RHC
identifying its own best practices and the outcomes of an RHC's
individualized QAPI program than in specific steps the RHC takes to
achieve the improvement. A more moderate QAPI requirement would allow
an RHC the flexibility to use staff and other resources in ways that
more directly support its needs. An RHC can design a program to analyze
its own organizational processes, functions, and services, while still
being held accountable for results. This decision would allow each RHC
the flexibility to fulfill this requirement based on its resources.
D. Conclusion
We do not expect a significant change in the operations of RHCs or
FQHCs generally, nor do we believe a substantial number of small
entities in the community, including RHCs, FQHCs, and a substantial
number of small rural hospitals, would be affected adversely by these
changes.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the OMB.
List of Subjects
42 CFR Part 405
Administrative practice and procedure, Health facilities, Health
professions, Kidney diseases, Medical devices, Medicare, Reporting and
recordkeeping requirements, Rural areas, X-rays.
42 CFR Part 410
Health facilities, health professions, Kidney diseases,
Laboratories, Medicare, Reporting and recordkeeping requirements, Rural
areas, X-rays.
42 CFR Part 491
Grant programs--health, Health facilities, Medicaid, Medicare,
Reporting and recordkeeping requirements, Rural areas.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services proposes to amend 42 CFR chapter IV as set forth
below:
PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED
Subpart X--Rural Health Clinic and Federally Qualified Health
Center Services
1. The authority citation for subpart X continues to read as
follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
2. Section 405.2401(b) is amended by--
A. Adding the definitions of ``clinical social worker'' and
``employee'' in alphabetical order.
B. Republishing the introductory text of the definition of
``Federally qualified health center'' and revising paragraph (1) of
that definition.
C. Adding the word ``Certified'' before ``Nurse-midwife'' in the
definition of ``Nurse-midwife,'' changing the ``N'' of ``Nurse-
midwife'' to lower case, and putting the definition in alphabetical
order.
D. Removing the definition of ``nurse practitioner and physician
assistant''.
E. Adding the definitions of ``nurse practitioner'' and ``physician
assistant'' in alphabetical order.
F. Revising the definition of ``rural health clinic.''
The revisions and additions read as follows:
Sec. 405.2401 Scope and definitions.
* * * * *
(b) * * *
Clinical social worker (CSW) means an individual who has the
following qualifications:
(1) Possesses a doctoral or master's degree in social work.
(2) After obtaining a doctoral or master's degree in social work,
has performed at least 2 years of supervised clinical social work.
(3) Either is licensed or certified as a CSW by the State in which
the individual practices or, in the case of an individual in a State
that does not provide for licensure or certification, has completed at
least 2 years or 3,000 hours of post-master's degree clinical social
work practice under the supervision of a qualified master's degree
social worker in an appropriate setting such as a hospital, clinic, or
SNF.
(4) Is employed by or under contract with the RHC or FQHC to
furnish diagnostic and therapeutic mental health services.
* * * * *
Employee means any individual who, under the common law rules that
apply
[[Page 36715]]
in determining the employer-employee relationship (as applied for
purposes of section 3121(d)(2) of the Internal Revenue Code of 1986),
is considered to be employed by, or an employee of, an entity.
(Application of these common law rules is discussed in 20 CFR 404.1007
and 26 CFR 31.3121(d)-1(c).)
Federally qualified health center (FQHC) means an entity that has
entered into an agreement with CMS to meet Medicare program
requirements under Sec. 405.2434 and--
(1) Is receiving a grant under section 330 of the Public Health
Service (PHS) Act, or is receiving funding from such a grant under a
contract with a recipient of such a grant and meets the requirements to
receive a grant under section 330 of the PHS Act;
* * * * *
Nurse practitioner (NP) means a registered professional nurse who
is currently licensed to practice in the State, who meets the State's
requirements governing the qualifications of nurse practitioners, and
who meets one of the following conditions:
(1) Is currently certified as a primary care nurse practitioner by
the American Nurses' Association or by the National Board of Pediatric
Nurse Practitioners and Associates.
(2) Has satisfactorily completed a formal academic 1-year
educational program that--
(i) Prepares registered nurses to perform an expanded role in the
delivery of primary care;
(ii) Includes at least 4 months (in the aggregate) of classroom
instruction and a component of supervised clinical practice; and
(iii) Awards a degree, diploma, or certificate to persons who
successfully complete the program.
(3) Has successfully completed a formal educational program (for
preparing registered nurses to perform an expanded role in the delivery
of primary care) that does not meet the requirements of paragraph (2)
of this definition, and has been performing an expanded role in the
delivery of primary care for a total of 12 months during the 18-month
period immediately preceding the effective date of this subpart.
* * * * *
Physician assistant means a person who meets the applicable State
requirements governing the qualifications for assistants to primary
care physicians, and who meets at least one of the following
conditions:
(1) Is currently certified by the National Commission on
Certification of Physician Assistants to assist primary care
physicians.
(2) Has satisfactorily completed a program for preparing physician
assistants that meets all of the following requirements:
(i) Was at least 1 academic year in length.
(ii) Consisted of supervised clinical practice and at least 4
months (in the aggregate) of classroom instruction directed toward
preparing students to deliver health care.
(iii) Was accredited by the American Medical Association's
Committee on Allied Health Education and Accreditation.
(3) Has satisfactorily completed a formal educational program (for
preparing physician assistants) that does not meet the requirements of
paragraph (2) of this definition and assisted primary care physicians
for a total of 12 months during the 18-month period that ended on
December 31, 1986.
* * * * *
Rural health clinic (RHC) means an entity that meets the following
requirements:
(1) The requirements specified in section 1861(aa)(2) of the Act
and part 491 of this chapter concerning RHC services and conditions for
approval.
(2) Has filed an agreement with CMS that meets the basic
requirements described in Sec. 405.2402 to provide RHC services under
Medicare.
* * * * *
Sec. 405.2402 [Amended]
3. Amend Sec. 405.2402(d) by removing ``he'' and adding ``the
Secretary'' in its place.
Sec. 405.2404 [Amended]
4. Amend Sec. 405.2404(a)(2)(ii) by removing ``he'' and adding
``the Secretary'' in its place.
5. Revise Sec. 405.2410 to read as follows:
Sec. 405.2410 Application of Part B deductible and coinsurance.
(a) Application of deductible. (1) Medicare payment for RHC
services begins only after the beneficiary has incurred the deductible.
Medicare applies the Medicare Part B deductible as follows:
(i) If the deductible is fully met by the beneficiary before the
RHC visit, Medicare pays 80 percent of the all-inclusive rate.
(ii) If the deductible is not fully met by the beneficiary before
the visit and the amount of the RHC's reasonable customary charge for
the service that is applied to the deductible is--
(A) Less than the all-inclusive rate, the amount applied to the
deductible is subtracted from the all-inclusive rate and 80 percent of
the remainder, if any, is paid to the RHC; or
(B) Equal to or exceeds the all-inclusive rate, no payment is made
to the RHC.
(2) Medicare payment for FQHC services is not subject to the usual
Part B deductible.
(b) Application of coinsurance. The beneficiary is responsible for
the coinsurance amount.
(1) For any one service provided by an RHC--
(i) If the deductible has already been met, beneficiary coinsurance
liability must not exceed 20 percent of the clinic's reasonable
customary charge for the covered service;
(ii) If the deductible has not already been met, the beneficiary
coinsurance liability must not exceed 20 percent of any remainder
amount after deducting the unmet deductible from the clinic's
reasonable customary charge for the covered service.
(2) The beneficiary's deductible and coinsurance liability for any
one service furnished by the RHC may not exceed 20 percent of the
reasonable amount customarily charged by the RHC for that particular
service.
(3) Except for services provided under Medicare Advantage plans to
FQHCs in accordance with section 1833(a)(3)(B) of the Act, the
coinsurance liability may not exceed 20 percent of the reasonable
amount customarily charged by the FQHC for the particular service.
6. Section 405.2411 is amended by--
A. Revising paragraph (a) introductory text.
B. Amending paragraphs (a)(1) through (a)(3) by removing the ``;''
at the end of each paragraph and adding a ``.'' in its place.
C. Amending paragraph (a)(4) by removing the ``; and'' at the end
of the paragraph and adding ``.'' in its place.
D. Adding new paragraphs (a)(6) through (a)(8).
E. Revising paragraph (b).
F. Adding a new paragraph (c).
The revisions and additions read as follows:
Sec. 405.2411 Scope of benefits.
(a) Rural health clinic services reimbursable under this part are
as follows:
* * * * *
(6) Certified nurse-midwife (CNM) services.
(7) Clinical psychologists (CP) and clinical social worker (CSW)
services specified in Sec. 405.2450 of this subpart.
(8) Service and supplies furnished as an incident to CP or CSW
services, as specified in Sec. 405.2452 of this subpart.
(b) RHC services are covered when furnished in an RHC setting or
other
[[Page 36716]]
outpatient setting, including a patient's place of residence or a
skilled nursing facility.
(c) RHC services are not covered in a hospital, as defined in
section 1861(e)(1) of the Act, or a critical access hospital.
7. Section 405.2414 is amended by--
A. Revising the section heading.
B. Revising paragraph (a)(1).
C. Adding the word ``certified'' before ``nurse-midwife'' in
paragraph (a)(4).
D. Adding the word ``certified'' before ``nurse-midwives'' in
paragraph (c).
The revisions read as follows:
Sec. 405.2414 Nurse practitioner (NP), physician assistant (PA), and
certified nurse-midwife (CNM) services.
(a) * * *
(1) Furnished by a nurse practitioner, physician assistant or
certified nurse-midwife, who is employed by, or receives compensation
from, the rural health clinic;
* * * * *
8. Amend Sec. 405.2415 by--
A. Revising the section heading.
B. Revising the introductory text of paragraph (a).
C. Revising paragraph (a)(4).
D. Revising paragraph (b).
The revisions read as follows:
Sec. 405.2415 Services and supplies incident to a clinical
psychologist (CP), clinical social worker (CSW), nurse practitioner
(NP), physician assistant (PA), or certified nurse mid-wife (CNM)
services.
(a) Services and supplies incident to a clinical psychologist's or
clinical social worker's, nurse practitioner's, physician assistant's,
or certified nurse-midwife's services are reimbursable under this
subpart if the service or supply is--
* * * * *
(4) Furnished under the direct, personal supervision of a nurse
practitioner, physician assistant, certified nurse-midwife, clinical
psychologist, clinical social worker, or physician; and
* * * * *
(b) The direct personal supervision requirement is met in the case
of a nurse practitioner, physician assistant, certified nurse-midwife,
nurse practitioner, clinical psychologist, or clinical social worker
only if the person is permitted to supervise those services under the
written policies governing the RHC.
* * * * *
Sec. 405.2448 [Amended]
9. Amend Sec. 405.2448 by removing and reserving paragraph (d).
10. Section 405.2462 is revised to read as follows:
Sec. 405.2462 Payment for rural health clinic services and Federally
qualified health center services.
(a) General rules. (1) RHCs and FQHCs are paid on the basis of an
all-inclusive rate per visit, subject to a payment limit.
(2) The Medicare Administrative Contractor or fiscal intermediary
determines the all-inclusive rate in accordance with this subpart and
instructions issued by CMS.
(b) Rules for RHCs. RHCs must meet the following requirements:
(1) Does not share space, staff, supplies, records, and other
resources during RHC hours of operation with a private Medicare or
Medicaid approved or certified practice owned, controlled or operated
by the same physicians and nonphysician practitioners that staff the
RHC as employees or contractors; and
(2) If sharing a multipurpose clinic with other types of health
providers or suppliers, appropriately allocates and excludes from the
RHC cost report the net non-RHC costs associated with the sharing of
common space, medical support staff, or other physical resources.
(3) If an RHC is an integral and subordinate part of a hospital, it
can receive an exception to the per visit payment limit if the hospital
has fewer than 50 beds as determined by using one of the following
methods:
(i) The determination of the number of beds at Sec. 412.105(b) of
this chapter.
(ii) The hospital's average daily patient census count of those
beds described in Sec. 412.105(b) of this chapter and the hospital
meets all of the following conditions:
(A) It is a sole community hospital as determined in accordance
with Sec. 412.92 or essential access community hospital as determined
in accordance with Sec. 412.109(a) of this chapter.
(B) It is located in a level 9 or 10 Rural-Urban Commuting Area
(RUCA).
(C) It has an average daily patient census that does not exceed 40.
(c) Payment procedures. To receive payment, an RHC or FQHC must
follow the payment procedures specified in Sec. 410.165(a) of this
chapter.
(d) Mental health limitation. Payment for the outpatient treatment
of mental, psychoneurotic, or personality disorders is subject to the
limitations on payment in Sec. 410.155 of this chapter.
11. In Sec. 405.2466 paragraph (b)(1)(iii) is revised to read as
follows:
Sec. 405.2466 Annual reconciliation.
* * * * *
(b) * * *
(1) * * *
(iii) Medicare payment to the RHC or FQHC is equal to its
reasonable costs less aggregate coinsurance and deductible amounts
billable, but in no case may total Medicare payment exceed 80 percent
of reasonable costs.
* * * * *
Sec. 405.2468 [Amended]
12. In Sec. 405.2468 paragraph (b)(1) is revised by removing the
parenthetical statement ``(RHCs are not paid for services furnished by
contracted individuals other than physicians.)''
PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS
13. The authority citation for part 410 continues to read as
follows:
Authority: Secs. 1102, 1834, 1871, and 1893 of the Social
Security Act (42 U.S.C. 1302, 1395m, 1395hh, and 1395ddd).
14. Section 410.150 is amended by--
A. Revising the first sentence of paragraph (b)(15).
B. Adding a new paragraph (b)(20).
The revision and addition read as follows:
Sec. 410.150 To whom payment is made.
* * * * *
(b) * * *
(15) Except for certain physician assistant services provided in a
rural health clinic owned by a physician assistant, as specified in
paragraph (b)(20) of this section, to the qualified employer of a
physician assistant for professional services furnished by the
physician assistant and for services and supplies furnished incident to
his or her services. * * *
* * * * *
(20) To a physician assistant who was the owner of a rural health
clinic as described Sec. 405.2401(b) of this subchapter. Payment is
made to such physician assistant for services and supplies furnished
incident to his or her services only if--
(i) No facility, other provider charges, or other amount has been
paid for services furnished by such physician assistant; and
(ii) The physician assistant owned the rural health clinic for a
continuous period beginning on or before August 4, 1997 and ending on
the date that the Secretary determines that the clinic no longer meets
the requirements of section 1861(aa)(2) of the Act.
PART 491--CERTIFICATION OF CERTAIN HEALTH FACILITIES
15. The authority citation for part 491 continues to read as
follows:
Authority: Sec. 1102 of the Social Security Act (42 U.S.C.
1302); and sec. 353 of the Public Health Service Act (42 U.S.C.
263a).
[[Page 36717]]
16. Section 491.2 is revised to read as follows:
Sec. 491.2 Definitions.
As used in this subpart, unless the context indicates otherwise:
Certified nurse-midwife (CNM), clinical social worker (CSW), nurse
practitioner (NP), physician, and physician assistant (PA) mean an
individual who has the qualifications for such practitioner set forth
in Sec. 405.2401 of this chapter.
Clinical psychologist (CP) means an individual who has
qualifications as defined in Sec. 405.2450 of this chapter.
Nonurban area means an area that is not delineated as an urbanized
area by the U.S. Census Bureau.
Rural area means an area that is not delineated as an urbanized
area by the U.S. Census Bureau.
Rural health clinic means a facility as defined in Sec.
405.2401(b).
Shortage area means a geographic area that meets one of the
following criteria:
(1) Designated by the Secretary as a geographic primary care health
professional shortage area under section 332(a)(1)(A) of the Public
Health Service Act (PHS Act);
(2) Designated by the Secretary as a population group primary care
HPSA under section 332(a)(1)(B) of the PHS Act;
(3) Designated by the Secretary as a medically underserved area
(but not as a medically underserved population group) under section
330(b)(3) of the PHS Act; or
(4) Designated by the chief executive officer of the State and
certified by the Secretary as an area with a shortage of personal
health services under section 6213(c) of the Omnibus Budget
Reconciliation Act of 1989.
17. Section 491.3 is revised to read as follows:
Sec. 491.3 General certification requirements.
(a) General. (1) RHCs participate in Medicare in accordance with an
agreement as specified in Sec. 405.2402 through Sec. 405.2404 of this
chapter.
(2) If CMS approves or disapproves the participation request of a
prospective RHC, CMS notifies the appropriate State agency.
(3) CMS deems an entity that is approved for Medicare participation
as an RHC to meet the standards for certification under Medicaid.
(b) Permanent and mobile units. An RHC and an FQHC may be located
in a permanent or a mobile unit.
(1) Permanent unit. The objects, equipment, and supplies necessary
for the provision of services furnished directly by the clinic or
center are housed in a permanent structure.
(2) Mobile unit. The objects, equipment, and supplies necessary for
the provision of services furnished directly by the clinic or center
are housed in a mobile structure, which has fixed, scheduled locations.
(3) Permanent unit in more than one location. If the RHC or FQHC
services are furnished at permanent units in more than one location,
each unit is independently considered for certification as an RHC or
FQHC and must meet the location requirements based on the physical
location of the clinic or center.
18. Section 491.4 is revised to read as follows:
Sec. 491.4 Compliance with State licensure laws.
The RHC or FQHC and its staff meet applicable Federal laws related
to the health and safety of patients as well as State licensure
requirements.
19. Section 491.5 is amended by revising paragraphs (a) through (e)
to read as follows:
Sec. 491.5 Location of clinic.
(a) General location requirements.
(1) An existing RHC or an applicant requesting entrance into the
Medicare program as an RHC--
(i) Is located in a rural area that is currently designated as a
shortage area as defined in Sec. 491.2; and
(ii) The designation of such shortage area has been made or updated
during the past 3 years.
(2) An FQHC is located in a rural or urban area that is designated
as either a medically underserved area or includes a medically
underserved population group.
(b) Location exception requirements. An RHC may be considered for
an exception to the location requirements specified in Sec.
491.5(a)(1) if the clinic--
(1)(i) Is in an area currently classified by the U.S. Census Bureau
as an urbanized area; or
(ii) Is in an area not currently designated as a shortage area.
(2)(i) Is located in an area that has been classified as an
Urbanized Area by the U.S. Census Bureau and is in a level 4 or higher
RUCA; and
(ii) Demonstrates that at least 51 percent of the clinic's patients
reside in an adjacent nonurbanized area.
(3) Meets the essential provider criteria specified in paragraph
(c) of this section.
(c) Essential provider criteria. CMS grants essential provider
status is for a period of 3 years. At the end of the 3-year period, the
clinic may reapply for continued essential provider status if an
exception is still needed. To receive an exception to the location
requirements, an RHC must provide documentation to support that it
meets one of the following conditions:
(1) Sole community provider. The RHC is the only participating
primary care provider that meets either of the following criteria:
(i) Is at least 25 miles from the nearest participating primary
care provider.
(ii) Is at least 15 miles but less than 25 miles from the nearest
participating primary care provider and demonstrates that it is more
than 30 minutes from the nearest primary care provider based on local
topography, predictable weather conditions, or posted speed limits. For
purposes of this exception, a participating primary care provider means
another RHC, FQHC, or other primary care provider that actively is
accepting and treating Medicare, Medicaid, low-income and uninsured
patients (regardless of their ability to pay).
(2) Major community provider. The RHC must meet the following
conditions to be considered a major community provider:
(i) Has a Medicare, Medicaid, low-income and uninsured patient
utilization rate greater than or equal to 51 percent or a low-income
patient utilization rate greater than or equal to 31 percent.
(ii) Is actively accepting and treating a major share of the
Medicare, Medicaid, low-income, and uninsured patients (regardless of
their ability to pay) compared to other participating primary care
providers that are within 25 miles of the RHC.
(3) Specialty clinic: Obstetrics/gynecology (ob/gyn) or pediatrics.
The RHC must meet all the following conditions to be considered a
specialty clinic:
(i) Exclusively provides ob/gyn or pediatric health services.
(ii) Is the sole provider or major source of ob/gyn or pediatrics
health services for Medicare (when applicable), Medicaid, low-income,
and uninsured patients (regardless of their ability to pay) and that
meets either of the following conditions:
(A) Is at least 25 miles from the nearest participating primary
care provider of ob/gyn or pediatric services; or
(B) Is at least 15 miles but less than 25 miles from the nearest
participating primary care provider of ob/gyn or pediatric services and
can demonstrate that it is more than 30 minutes from the nearest
primary care provider providing these services based on local
[[Page 36718]]
topography, predictable weather conditions, or posted speed limits.
(iii) Is actively accepting and treating Medicare (where
applicable), Medicaid, low-income, and uninsured patients;
(iv) Has a Medicare, Medicaid, low-income patient and uninsured
patient utilization rate greater than or equal to 31 percent.
(v) Provides ob/gyn or pediatric health services onsite to clinic
patients.
(4) Extremely rural community provider. The RHC must meet the
following conditions to be considered an extremely rural community
provider:
(i) Is actively accepting and treating Medicare, Medicaid, low-
income, and uninsured patients (regardless of their ability to pay).
(ii) Is located in a frontier county (6 or less persons per square
mile) or in a Rural-Urban Commuting Area level 10 area.
(d) Termination. (1) CMS decertifies a clinic from participation in
the Medicare program as an RHC, effective 180 days after the date that
the RHC no longer meets the location requirements, unless--
(i) An application to update the shortage area designation has been
received by the Health Resources and Services Administration (HRSA) not
later than 3 years from the date of the last designation; or
(ii) The RHC has submitted an application for an exception to the
location requirement as specified in paragraph (e) of this section and
meets the exception standards set forth in paragraphs (b) and (c) of
this section.
(2) CMS may terminate RHC status at any time if it determines that
the RHC is not in compliance with any certification requirements.
(e) Process for essential provider status.
(1) If HRSA has not received an application to update a designation
by the end of the 3 years from the date of the previous designation, an
RHC in such area has 90 days from the end of the 3-year period to
submit its request to CMS for an exception in order to continue to be
considered to be an essential provider.
(2) If HRSA has proposed for withdrawal or withdrawn a designation,
the RHC in such area must submit its request to CMS for an exception in
order to continue to be considered an essential provider 90 days from
the date the designation was proposed for withdrawal or withdrawn.
(3) If HRSA has disapproved an application to update a designation,
the RHC in such area has 90 days from the date of the disapproval to
submit a request for a location exception in order to be considered an
essential provider.
(4) An existing RHC may apply for an exception from decertification
by submitting to the appropriate CMS regional office a written request
with any necessary documentation demonstrating that it meets one of the
essential provider criteria specified in paragraph (c) of this section.
(5) CMS does not decertify an RHC that has submitted an application
for an exception within 90 days from the date that the RHC no longer
meets the location requirements while the application for an exception
is under review, for a period not to exceed 180 days from the date the
RHC no longer meets the location requirement, or the effective date of
the final rule, whichever is later. In rare circumstances, the CMS RO
may request an extension from the CMS Central Office if it has not been
possible to process the location exception request before the RHC would
be decertified.
(6) The CMS regional office may grant a 3-year exception based on
its review of an RHC request and other relevant information, if such
CMS regional office determines that the RHC is essential to the
delivery of primary care services that otherwise are not available in
the geographic area served by the RHC, as specified in paragraph (b) of
this section.
(7) At the end of the 3-year exception period, a clinic may renew
its essential provider status by submitting written assurances to the
appropriate CMS regional office that it continues to meet the
conditions specified in this section.
(8) An RHC that is located in an area for which an application to
update the designation has not been submitted to HRSA or has been found
by HRSA to not qualify for an eligible designation, and has not
submitted an application for an exception within 90 days of the date
that the designation is more than 3 years old, may continue to operate
as an RHC for 180 calendar days after the expiration of the applicable
3-year period, effective the last day of the month.
(9) A provider-based RHC that does not meet the location
requirements and does not qualify for an exception and has submitted an
application to CMS to be another type of Medicare provider that
requires a State survey for certification, may receive an additional
120 days extension of their status as an RHC while their application is
being processed.
* * * * *
20. Section 491.6 is amended by--
A. Adding paragraph (d).
B. Adding paragraph (e).
The additions read as follows:
Sec. 491.6 Physical plant and environment.
* * * * *
(d) Infection control. The RHC or FQHC must protect patients and
staff by maintaining and documenting an infection control process
that--
(1) Follows accepted standards of practice, including the use of
standard precautions, to prevent the transmission of infectious and
communicable diseases; and
(2) Is an integral part of the quality assessment and performance
improvement (QAPI) programs.
(e) Hours of operation. The clinic or center must post signs that
are noticeable and can be viewed by those with vision problems and
those in wheelchairs at or near the entrance to the facility to advise
the public of the days of the week and hours when services are
furnished.
21. Section 491.8 is amended by--
A. Revising paragraphs (a)(1), (a)(3), and (a)(6).
B. Adding paragraph (d).
The revisions and additions read as follows:
Sec. 491.8 Staffing and staff responsibilities.
(a) * * *
(1) (i) RHC or FQHC has a health care staff that includes one or
more physicians.
(ii) A RHC must employ one or more physician assistants or nurse
practitioners.
* * * * *
(3) The physician assistant, nurse practitioner, certified nurse-
midwife, clinical social worker, or clinical psychologist member of the
staff may be the owner or an employee of the clinic or center, or may
furnish services under contract to the clinic or center.
* * * * *
(6) A physician, nurse practitioner, physician assistant, certified
nurse-midwife, clinical social worker, or clinical psychologist is
available to furnish patient care services at all times the clinic or
center operates. In addition, for RHCs, a nurse practitioner, physician
assistant, or certified nurse-midwife is available to furnish patient
care services at least 50 percent of the time the RHC operates.
* * * * *
(d) Temporary staffing waiver. (1) CMS may grant a temporary waiver
of the RHC staffing requirements in paragraphs (a)(1)(ii) and (a)(6) of
this section for a 1-year period to a qualified RHC, if the RHC
requests a waiver and demonstrates that it has been unable,
[[Page 36719]]
despite reasonable efforts in the previous 90-day period, to hire a
certified nurse-midwife, nurse practitioner, or physician assistant to
furnish services at least 50 percent of the time the RHC provides
clinical services, or to hire a PA or NP as a direct employee.
(2) CMS terminates the RHC from participation in the Medicare
program, if the RHC is not in compliance with the provisions waived
under paragraphs (a)(1) and (a)(6) of this section at the expiration of
the waiver.
(3) The RHC may submit its request for an additional waiver of
staffing requirements under this paragraph no earlier than 6 months
after the expiration of the previous waiver.
22. Section 491.9 is amended by--
A. Revising paragraph (c)(2).
B. Revising paragraph (c)(3).
The revisions and addition read as follows:
Sec. 491.9 Provision of services.
* * * * *
(c) * * *
(2) Laboratory. These requirements apply to RHCs but not to FQHCs.
The clinic provides laboratory services in accordance with part 493 of
this chapter, which implements the provisions of section 353 of the
Public Health Service Act. The clinic provides basic laboratory
services essential to the immediate diagnosis and treatment of the
patient. See Sec. 405.2462 of this chapter for payment requirements
for clinical laboratory services furnished within the RHC setting.
These laboratory services include the following:
(i) Chemical examinations of urine by stick or tablet method or
both (including urine ketones).
(ii) Hemoglobin or hematocrit.
(iii) Blood glucose.
(iv) Examination of stool specimens for occult blood.
(v) Pregnancy tests.
(vi) Primary culturing for transmittal to a certified laboratory.
(3) Emergency. The clinic or center must--
(i) Provide medical emergency procedures as a first response to
common life-threatening injuries and acute illnesses;
(ii) Have available the drugs, biologicals, equipment, and
supplies, which are appropriate for the facility's patient population
and which are commonly used in emergency first response procedures; and
(iii) Provide training for staff in the provision of these
emergency procedures according to the clinic's or center's policies
that are consistent with commonly accepted practice as well as in
accordance with applicable Federal, State, and local laws.
* * * * *
23. Section 491.10 is amended by--
A. Revising paragraph (a)(3) introductory text.
B. Removing the ``;'' at the end of paragraphs (a)(3)(i) through
(a)(3)(iv) and adding a ``.'' in its place.
C. Adding a new paragraph (a)(3)(v).
The revision and addition read as follows:
Sec. 491.10 Patient health records.
(a) * * *
(3) For each patient receiving RHC or FQHC services at such
facility, the RHC or FQHC maintains a record that includes the
following, as applicable:
* * * * *
(v) Legible entries that are completed, dated, timed, and
authenticated promptly in written or electronic form by the person
responsible for ordering, providing, or evaluating the service. Any
entry in the patient health record must be identified and authenticated
promptly by the person making the entry. All entries in the patient
health record must be authenticated within 48 hours unless there is a
State law that designates a specific timeframe for the authentication
of entries.
* * * * *
24. Revise Sec. 491.11 to read as follows:
Sec. 491.11 Quality assessment and performance improvement for RHCs.
The RHC must develop, implement, evaluate, and maintain an
effective, ongoing, data-driven quality assessment and performance
improvement (QAPI) program. The self-assessment and performance
improvement program must be appropriate for the complexity of the RHCs
organization and services and focus on maximizing outcomes by improving
patient safety, quality of care, and patient satisfaction.
(a) Standard: Components of a QAPI program. The RHC's QAPI program
must include, but not be limited to, the use of objective measures to
evaluate the following:
(1) Organizational processes, functions, and services.
(2) Utilization of clinic services, including at least the number
of patients served and the volume of services.
(b) Standard: Program activities. (1) For each of the areas listed
in paragraph (a)(1) of this section, the RHC must do the following:
(i) Adopt or develop performance measures that reflect processes of
care and RHC operation and are shown to be predictive of desired
patient outcomes or to be the outcomes themselves.
(ii) Use the measures to analyze and track its performance.
(2) The RHC must set priorities for performance improvement,
considering either high-volume, high-risk services, the care of acute
and chronic conditions, patient safety, coordination of care,
convenience and timeliness of available services, or grievances and
complaints.
(3) The RHC must conduct distinct improvement projects. The number
and frequency of distinct improvement projects conducted by the RHC
must reflect the scope and complexity of the clinic's services and
available resources.
(4) An RHC that develops and implements an information technology
system explicitly designed to improve patient safety and quality of
care meets the requirement for a project under this section.
(5) The RHC must maintain records on its QAPI program and quality
improvement projects.
(c) Standard: Program responsibilities. The RHC's professional
staff, administrative officials, and governing body (if applicable) are
responsible for the following:
(1) Identifying or approving QAPI priorities.
(2) Ensuring that QAPI activities that are developed to address
identified priorities are implemented and evaluated.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: October 11, 2007.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicaid Services.
Approved: February 28, 2008.
Michael O. Leavitt,
Secretary.
Editorial Note: This document was received at the Office of the
Federal Register on June 9, 2008.
[FR Doc. E8-13280 Filed 6-26-08; 8:45 am]
BILLING CODE 4120-01-P